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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04456920
Other study ID # PROICM 2020-06 BIO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 9, 2021
Est. completion date April 19, 2024

Study information

Verified date December 2023
Source Institut du Cancer de Montpellier - Val d'Aurelle
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Each year, approximately 1500 breast biopsies (1000 microbiopsies and 500 macrobiopsies) are performed in the radiologic department of the Montpellier Cancer Institute (ICM). This exam, which is relatively easy for the radiologist, can however lead to major anxiety for patients. Indeed, previous studies show that about 50% of women undergoing a breast biopsy have significant anxiety affects. Anxiety associated with the risks of biopsy, potential breast cancer diagnosis and/or lack of routine sedation procedures increase patient concerns. Distress prior to biopsy is associated with greater pain and discomfort during the procedure. The psychological distress that persists after the biopsy is related to a worse psychological management of side effects of the biopsy breast (e.g., sensitivity, skin irritation). Limiting apprehension, worry and anxiety induced by the uncertainty linked to the biopsy results and the biopsy-related pain should be an integral part of the medical care through the patient follow-up during, after and until the diagnosis is announced. In light of these challenges, new alternative methods are emerging to enhance patient knowledge, develop procedural skills, improve confidence and mitigate procedural anxiety. However, to our knowledge, few methods have been developed during this period of 'waiting-time'. Currently, only care instructions and a consultation to announce the results (about 10 days after the procedure) are proposed to patients at the end of biopsy. Patients are also encouraged to call if they suspect complications such as infection or bleeding. In this context, the investigators propose to integrate a pain management after biopsy via e-health system through the patient's medical care. Radiologist/patient communication could have an impact on patients' anxiety and health-related issues, given the challenging nature of discussions around need for breast biopsy and potential implications of the results. Indeed, paying attention and focusing on symptoms as patients experience them improves their empowerment and their adjustment to the disease. Web-based systems that can provide electronic-Patient reported Outcomes (e-PRO) have been shown to prompt clinicians to intensify symptom management, to improve symptom control and to enhance patient-clinician communication patient satisfaction, as well as well-being. In addition, it is known that improved communication between patients and medical staff to less anxiety after a biopsy and that anxiety is related to pain. Taken as a whole, these elements encourage the integration of e-health and e-PRO for the management of pain and anxiety in patients undergoing a biopsy. The benefits of e-PRO are still being discussed in terms of quality of life (Qol) and psychological distress. The investigator propose to integrate two types of e-health intervention: 1/e-PRO collected by connected objects (smartphone or tablet) as they were used in previous studies, and 2/ e-PRO collected by a phone consultation, which values human communication between the medical staff and the patient. In case of significant pain, the collection of e-PRO by any of these e-health interventions will generate an alert and a reactive and responsive care. In fine, the purpose of this research is to improve the medical organization and care of post-biopsy patients by proposing an innovative connected patient technology, regardless of their remoteness from the hospital. Social inequalities will be reduced by lending a tablet to patients who do not have such a device with a 4G key.


Description:

The primary objective is to compare the benefit of intervention by e-health (phone consultation with a professional or connected objects (smartphone or tablet)) with the standard follow up of the pain intensity of patients 4 days (D4) after un breast biopsy. This study is a Monocentric, prospective, open-labeled, randomized controlled trial. A total of 192 patients (64 patients in group control vs 64 patients in experimental group 1 (PRO gathered via a phone consultation) and 64 patients in experimental group 2 (e-PRO self-completed via connected objects (tablet/phone) will be required including 10% of lost-to-follow-up patients. The inclusion period would be 8 months


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date April 19, 2024
Est. primary completion date November 20, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with diagnostic breast biopsy at ICM - Age > 18 years - Informed patient and signed informed consent received - Affiliation to a social security system Exclusion Criteria: - Patient without phone number - Patient with previous biopsy in 6 months prior to study - Pregnant and breastfeeding woman - Patient whose regular follow-up is initially impossible for psychological, family, social or geographical reasons - Patient under legal protection (guardianship, curatorship or safeguarding of justice)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
phone consultation
At D1, D2 and D3, patients in the experimental group 1 will receive a call from a neuro-psychologist during which pain, anxiety and esthetical biopsy impact will be assessed using numeric or visual analog scales during a semi-direct interview. During this call, any adverse events related to the breast biopsy will also be noted, as well as the amount, nature and dose of analgesics, anxiolytics, anti-depressants, anti-inflammatory and hypnotics taken linked to the biopsy. If detected, pain or significative distress would be specifically managed.
e-PRO self-completed via connected objects (tablet/phone)
Patients in the experimental group 2 will be asked by SMS or notification to connect to the application in order to complete online the numeric and visual anog scales of pain, anxiety and esthetical impact. Any adverse events related to the breast biopsy will also be noted online, as well as the amount, nature and dose of analgesics, anxiolytics, anti-depressants, anti-inflammatory and hypnotics taken for the biopsy. If detected, pain or significative distress would be specifically managed
phone consultation
At D4 post biopsy, all patients (of the 3 groups) will receive a phone call from a neuro-psychologist to assess pain, anxiety and esthetical impact, using numeric scales, and to collect adverse events. If detected, pain or significative distress would be specifically managed.
visit
And at D10 (+/- 2 days), all patients will physically come to the Cancer center in the consultation of biopsy results announcement. At the beginning of this consultation, pain, anxiety and esthetical impact will be assessed using numeric scales. . The adverse events related to the breast biopsy will be collected as well as the amount, nature and dose of analgesics, anxiolytics, anti-depressants, anti-inflammatory and hypnotics taken for the biopsy and its findings. Insomnia will be evaluated by the Insomnia Severity Index. If detected, pain or significative distress would be managed as usually in the center.

Locations

Country Name City State
France Icm Val D'Aurelle Montpellier Hérault

Sponsors (1)

Lead Sponsor Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (31)

Aitken RC. Measurement of feelings using visual analogue scales. Proc R Soc Med. 1969 Oct;62(10):989-93. No abstract available. — View Citation

Andrykowski MA, Carpenter JS, Studts JL, Cordova MJ, Cunningham LL, Beacham A, Sloan D, Kenady D, McGrath P. Psychological impact of benign breast biopsy: a longitudinal, comparative study. Health Psychol. 2002 Sep;21(5):485-94. — View Citation

Atkinson TM, Ryan SJ, Bennett AV, Stover AM, Saracino RM, Rogak LJ, Jewell ST, Matsoukas K, Li Y, Basch E. The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review. Support Care Cancer. 2016 Aug;24(8):3669-76. doi: 10.1007/s00520-016-3297-9. Epub 2016 Jun 3. — View Citation

Basch E, Artz D, Dulko D, Scher K, Sabbatini P, Hensley M, Mitra N, Speakman J, McCabe M, Schrag D. Patient online self-reporting of toxicity symptoms during chemotherapy. J Clin Oncol. 2005 May 20;23(15):3552-61. doi: 10.1200/JCO.2005.04.275. — View Citation

Berry DL, Blumenstein BA, Halpenny B, Wolpin S, Fann JR, Austin-Seymour M, Bush N, Karras BT, Lober WB, McCorkle R. Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol. 2011 Mar 10;29(8):1029-35. doi: 10.1200/JCO.2010.30.3909. Epub 2011 Jan 31. — View Citation

Chen J, Ou L, Hollis SJ. A systematic review of the impact of routine collection of patient reported outcome measures on patients, providers and health organisations in an oncologic setting. BMC Health Serv Res. 2013 Jun 11;13:211. doi: 10.1186/1472-6963-13-211. — View Citation

Chen PY, Yang CM, Morin CM. Validating the cross-cultural factor structure and invariance property of the Insomnia Severity Index: evidence based on ordinal EFA and CFA. Sleep Med. 2015 May;16(5):598-603. doi: 10.1016/j.sleep.2014.11.016. Epub 2015 Feb 12. — View Citation

Cordova MJ, Cunningham LL, Carlson CR, Andrykowski MA. Social constraints, cognitive processing, and adjustment to breast cancer. J Consult Clin Psychol. 2001 Aug;69(4):706-11. — View Citation

den Heijer M, Seynaeve C, Vanheusden K, Duivenvoorden HJ, Bartels CC, Menke-Pluymers MB, Tibben A. Psychological distress in women at risk for hereditary breast cancer: the role of family communication and perceived social support. Psychooncology. 2011 Dec;20(12):1317-23. doi: 10.1002/pon.1850. Epub 2010 Oct 5. — View Citation

Denis F, Lethrosne C, Pourel N, Molinier O, Pointreau Y, Domont J, Bourgeois H, Senellart H, Tremolieres P, Lizee T, Bennouna J, Urban T, El Khouri C, Charron A, Septans AL, Balavoine M, Landry S, Solal-Celigny P, Letellier C. Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx029. Erratum In: J Natl Cancer Inst. 2018 Apr 1;110(4):436. — View Citation

Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027. Erratum In: JAMA. 2003 Feb 26;289(8):987. — View Citation

Dorfman CS, Lamb E, Van Denburg A, Wren AA, Soo MS, Faircloth K, Gandhi V, Shelby RA. The relationship between holding back from communicating about breast concerns and anxiety in the year following breast biopsy. J Psychosoc Oncol. 2018 Mar-Apr;36(2):222-237. doi: 10.1080/07347332.2017.1395939. Epub 2018 Jan 11. — View Citation

Elkins G, Staniunas R, Rajab MH, Marcus J, Snyder T. Use of a numeric visual analog anxiety scale among patients undergoing colorectal surgery. Clin Nurs Res. 2004 Aug;13(3):237-44. doi: 10.1177/1054773803262222. — View Citation

Grimm LJ, Shelby RA, Knippa EE, Langman EL, Miller LS, Whiteside BE, Soo MSC. Patient Perceptions of Breast Cancer Risk in Imaging-Detected Low-Risk Scenarios and Thresholds for Desired Intervention: A Multi-Institution Survey. J Am Coll Radiol. 2018 Jun;15(6):911-919. doi: 10.1016/j.jacr.2018.02.010. Epub 2018 Mar 30. — View Citation

Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016. — View Citation

Hodkinson B, Maheu E, Michon M, Carrat F, Berenbaum F. Assessment and determinants of aesthetic discomfort in hand osteoarthritis. Ann Rheum Dis. 2012 Jan;71(1):45-9. doi: 10.1136/ard.2011.153965. Epub 2011 Sep 6. — View Citation

Iwamitsu Y, Shimoda K, Abe H, Tani T, Okawa M, Buck R. Anxiety, emotional suppression, and psychological distress before and after breast cancer diagnosis. Psychosomatics. 2005 Jan-Feb;46(1):19-24. doi: 10.1176/appi.psy.46.1.19. — View Citation

Kotronoulas G, Kearney N, Maguire R, Harrow A, Di Domenico D, Croy S, MacGillivray S. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J Clin Oncol. 2014 May 10;32(14):1480-501. doi: 10.1200/JCO.2013.53.5948. Epub 2014 Apr 7. — View Citation

Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240-8. doi: 10.1001/jama.2014.7689. — View Citation

Lampic C, Thurfjell E, Bergh J, Sjoden PO. Short- and long-term anxiety and depression in women recalled after breast cancer screening. Eur J Cancer. 2001 Mar;37(4):463-9. doi: 10.1016/s0959-8049(00)00426-3. — View Citation

Manne S, Myers S, Ozga M, Kissane D, Kashy D, Rubin S, Heckman C, Rosenblum N. Holding back sharing concerns, dispositional emotional expressivity, perceived unsupportive responses and distress among women newly diagnosed with gynecological cancers. Gen Hosp Psychiatry. 2014 Jan-Feb;36(1):81-7. doi: 10.1016/j.genhosppsych.2013.10.001. Epub 2013 Oct 9. — View Citation

Mema E, Cho E, Ryu YK, Jadeja P, Wynn R, Taback B, Ha R. In the Setting of Negative Mammogram, Is Additional Breast Ultrasound Necessary for Evaluation of Breast Pain? Curr Probl Diagn Radiol. 2019 Mar-Apr;48(2):117-120. doi: 10.1067/j.cpradiol.2017.12.007. Epub 2018 Jan 9. — View Citation

Miller LS, Shelby RA, Balmadrid MH, Yoon S, Baker JA, Wildermann L, Soo MS. Patient anxiety before and immediately after imaging-guided breast biopsy procedures: impact of radiologist-patient communication. J Am Coll Radiol. 2013 Jun;10(6):423-31. doi: 10.1016/j.jacr.2012.11.005. Epub 2013 Mar 15. — View Citation

Pineault P. Breast Cancer Screening: Women's Experiences of Waiting for Further Testing. Oncol Nurs Forum. 2007 Jul;34(4):847-53. doi: 10.1188/07.ONF.847-853. — View Citation

Roark AA, Ebuoma LO, Ortiz-Perez T, Sepulveda KA, Severs FJ, Wang T, Benveniste AP, Sedgwick EL. Impact of Simulation-Based Training on Radiology Trainee Education in Ultrasound-Guided Breast Biopsies. J Am Coll Radiol. 2018 Oct;15(10):1458-1463. doi: 10.1016/j.jacr.2017.09.016. Epub 2017 Dec 6. — View Citation

Santana MJ, Feeny D, Johnson JA, McAlister FA, Kim D, Weinkauf J, Lien DC. Assessing the use of health-related quality of life measures in the routine clinical care of lung-transplant patients. Qual Life Res. 2010 Apr;19(3):371-9. doi: 10.1007/s11136-010-9599-3. Epub 2010 Feb 10. — View Citation

Seow H, Sussman J, Martelli-Reid L, Pond G, Bainbridge D. Do high symptom scores trigger clinical actions? An audit after implementing electronic symptom screening. J Oncol Pract. 2012 Nov;8(6):e142-8. doi: 10.1200/JOP.2011.000525. Epub 2012 Aug 21. — View Citation

Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4. — View Citation

Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24. doi: 10.1200/JCO.2004.06.078. — View Citation

Wilkie D, Lovejoy N, Dodd M, Tesler M. Cancer pain intensity measurement: concurrent validity of three tools--finger dynamometer, pain intensity number scale, visual analogue scale. Hosp J. 1990;6(1):1-13. doi: 10.1080/0742-969x.1990.11882662. — View Citation

Yennurajalingam S, Kang JH, Hui D, Kang DH, Kim SH, Bruera E. Clinical response to an outpatient palliative care consultation in patients with advanced cancer and cancer pain. J Pain Symptom Manage. 2012 Sep;44(3):340-50. doi: 10.1016/j.jpainsymman.2011.09.014. Epub 2012 Jun 13. — View Citation

* Note: There are 31 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary the benefit of intervention by e-health (phone consultation with a professional or connected objects (smartphone or tablet)) with the standard follow up of the pain intensity of patients 4 days (D4) after un breast biopsy Pain score assessed (by phone) via a numeric pain scale (from 0 "no pain" to 10 "maximal pain")completed 4 days after biopsy (Day 4). From date of randomization until the Day 4 post biopsy
Secondary the benefit of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of the pain intensity of patients during the consultation of results announcement (about Day 10) after a breast biopsy. Pain score assessed using a numeric pain scale (from 0 "no pain" to 10 "maximal pain") administered after to biopsy and during the consultation of results announcement (approximately Day 10). From date of randomization until the Day 10 post biopsy
Secondary the benefit according to the type of intervention by e-health (phone consultation with a professional or connected objects) on the pain intensity of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy. Pain score assessed using a numeric pain scale (from 0 "no pain" to 10 "maximal pain") administered after to biopsy, at 4 days and 10 days post biopsy From date of randomization until the Day 4 / Day 10 post biopsy
Secondary the benefit of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of the anxiety intensity of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy. Anxiety score assessed using a numeric anxiety scale (from 0 "no anxiety" to 10 "maximal anxiety") administered after to biopsy, at 4 days (Day 4) and 10 days (Day 10) From date of randomization until the Day 4 and Day 10 post biopsy
Secondary the benefit according to the type of intervention by e-health (phone consultation with a professional or connected objects) on the anxiety intensity of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy. Anxiety score assessed using a numeric anxiety scale (from 0 "no anxiety" to 10 "maximal anxiety") administered after to biopsy, at 4 days and 10 days post biopsy From date of randomization until the Day 4 and Day 10 post biopsy
Secondary the benefit of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of the esthetic impact of patients at 4 and 10 days (D4, D10) after a breast biopsy. Esthetic impact score assessed using a numeric esthetic scale (from 0 "no impact" to 100 "maximal impact") administered after to biopsy, at 4 days and 10 days post biopsy From date of randomization until the Day 4 and Day 10 post biopsy
Secondary the benefit according to the type of intervention by e-health (phone consultation with a professional or connected objects) on the esthetic impact of patients at 4 and 10 days (Day 4, Day 10) after a breast biopsy. Esthetic impact score assessed using a numeric esthetic scale (from 0 "no impact" to 100 "maximal impact") administered after to biopsy, at 4 days and 10 days post biopsy From date of randomization until the Day 4 and Day 10 post biopsy
Secondary the benefit of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of the insomnia of patients at 4 and 10 days after a breast biopsy. Insomnia score assessed using the Index of Severity of Insomnia administered (from 0 "no insomnia" to 28 "maximal insomnia") during the baseline visit and the consultation of results announcement. From date of randomization until the Day 10 post biopsy
Secondary the benefit according to the type of intervention by e-health (phone consultation with a professional or connected objects) on the insomnia of patients at 4 days (Day 4) and at 10 days (about Day 10), after a breast biopsy. Insomnia score assessed using the Index of Severity of Insomnia (from 0 "no insomnia" to 28 "maximal insomnia") administered at 10 days post biopsy From date of randomization until the Day 10 post biopsy
Secondary the benefit of intervention by e-health (phone consultation with a professional or connected objects) with the standard follow up of patient's management Number of alerts that generated a phone call or number of phone calls generated directly by the patient and patient care accordingly. From date of randomization until the Day 4 and the Day 10 post biopsy
Secondary the use of a biopsy-related drug intervention in patients with e-health interventions (phone consultation or smartphone), with the standard follow-up, at 10 days after a breast biopsy. Quantity, nature and dose of treatments used for the biopsy and its aftermath. From date of randomization until the Day 4 and Day 10 post biopsy
Secondary adverse events in patients with e-health interventions (phone consultation with a professional or connected objects), with the standard follow-up, during the consultation of results announcement (about D10) after a breast biopsy. Adverse event in particular bleeding and infection due to biopsy recorded at 4 days (Day 4) and during the consultation of results announcement (about Day 10) by NCI-CTCAE 5.0 From date of randomization until the Day 4 and the Day 10 post biopsy
Secondary assess satisfaction with specific study management. Number of positive responses to satisfaction questions related to the number of solicitations for the study and how interventions are communicated From date of randomization until the Day 4 and the Day 10 post biopsy
Secondary assess compliance. Rate of completion questionnaire (on the application) From date of randomization until the Day 3
Secondary assess compliance. numeric scale (likert scala : (from 0 "no satisfy" to 10 "maximal satisfy") From date of randomization until the Day 3
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