Digestive System Neoplasm Clinical Trial
— BCB-CBIO-DIGOfficial title:
Development of a Prospective Clinicobiological Database in Metastatic Digestive Cancers
Creation of a collection of blood samples that will be collected before and then under treatment in patients with digestive adenocarcinoma during the 1st and 2nd metastatic line and which, depending on scientific progress, can be used for research projects aimed at developing tailored patient management strategies.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | April 2026 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female = 18 years old 2. Histological documentation of adenocarcinoma of the colon or rectum, small intestine, pancreas, stomach, bile duct, oesophagus 3. Patient who will receive a first or second line metastatic chemotherapy and/or targeted therapy 4. Informed consent form (ICF) signed Exclusion Criteria: 1. Male or female < 18 years old 2. Non-adenocarcinoma histological type 3. Patient already undergoing specific treatment (chemotherapy and/or targeted therapy) in 1st or 2nd metastatic line 4. Pregnant and/or breastfeeding woman 5. Patient not affiliated to a social security system 6. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons 7. Patient who is included in a Phase I-II therapeutic trial modifying usual management and involving additional and specific blood samples |
Country | Name | City | State |
---|---|---|---|
France | Institut régional du cancer de Montpellier | Montpellier | Hérault |
Lead Sponsor | Collaborator |
---|---|
Institut du Cancer de Montpellier - Val d'Aurelle |
France,
Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. doi: 10.1016/S0140-6736(10)61121-X. Epub 2010 Aug 19. Erratum in: Lancet. 2010 Oct 16;376(9749):1302. — View Citation
Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26. — View Citation
Douillard JY, Oliner KS, Siena S, Tabernero J, Burkes R, Barugel M, Humblet Y, Bodoky G, Cunningham D, Jassem J, Rivera F, Kocákova I, Ruff P, Blasinska-Morawiec M, Šmakal M, Canon JL, Rother M, Williams R, Rong A, Wiezorek J, Sidhu R, Patterson SD. Panitumumab-FOLFOX4 treatment and RAS mutations in colorectal cancer. N Engl J Med. 2013 Sep 12;369(11):1023-34. doi: 10.1056/NEJMoa1305275. — View Citation
Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC, Simes RJ, Chalchal H, Shapiro JD, Robitaille S, Price TJ, Shepherd L, Au HJ, Langer C, Moore MJ, Zalcberg JR. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1757-65. doi: 10.1056/NEJMoa0804385. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of clinical risk factors for metastatic digestive cancer | Until the study completion : 54 months | ||
Primary | Number of biological risk factors for metastatic digestive cancer | Until the study completion : 54 months |
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