Carcinoma, Non-Small-Cell Lung Clinical Trial
Official title:
Utility of ctDNA In Predicting Whether Giving Adjuvant Chemotherapy In Patients With Stage IB-IIA Resected Non-small Cell Lung Cancer: A Prospective Cohort Study
NCT number | NCT05167604 |
Other study ID # | 777436 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 30, 2021 |
Est. completion date | December 2024 |
This clinical trial aims to explore the minimal residual disease (MRD) status of early NSCLC after curative surgery and the clinical outcomes of adjuvant chemotherapy. Next-generation sequencing technique will be used to examine the circulating tumor DNA (ctDNA) from MRD of 150 postoperative patients with stage IB-IIA NSCLC who received adjuvant chemotherapy.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2024 |
Est. primary completion date | September 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients aged between 18 and 70 years - Histological diagnosis of primary NSCLC - Patients received curative surgery for primary NSCLC - Tumor stage IB-IIA after curative-intent surgical resection - ECOG score: 0-1 - Participant is willing to use an acceptable form of contraception during the study. - Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: - The patient has received neoadjuvant therapy, including radiotherapy and chemotherapy, targeted therapy and immunotherapy - Patients are unwilling or unable to receive the curative-intent resection - Patients have or have had history of malignant tumor - Patients who suffer from severe uncontrolled disease that require systemic treatment or considered unsuitable for participating this trial due to other reasons by the investigator - Patients with severe gastrointestinal dysfunction, cardiac dysfunction, interstitial lung disease, etc. - Laboratory test results showed inadequate bone marrow or organ function - Blood transfusion during or within 2 weeks before the surgery - History of alcohol abuse or drug overdose - Pregnant or breastfeeding women - Patients who are currently or have participated in any other anti-tumor clinical trials - Inadequate baseline data, such as preoperative and postoperative blood samples (Lack of 2 consecutive blood test or a total of 3 blood samples), surgical tumor tissues, and ctDNA test. |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated The Second Affiliated Hospital of Air Force Medical University (Tangdu Hospital) | Xi'an | Baqiao |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
China,
Abbosh C, Birkbak NJ, Wilson GA, Jamal-Hanjani M, Constantin T, Salari R, Le Quesne J, Moore DA, Veeriah S, Rosenthal R, Marafioti T, Kirkizlar E, Watkins TBK, McGranahan N, Ward S, Martinson L, Riley J, Fraioli F, Al Bakir M, Grönroos E, Zambrana F, Endo — View Citation
Chin RI, Chen K, Usmani A, Chua C, Harris PK, Binkley MS, Azad TD, Dudley JC, Chaudhuri AA. Detection of Solid Tumor Molecular Residual Disease (MRD) Using Circulating Tumor DNA (ctDNA). Mol Diagn Ther. 2019 Jun;23(3):311-331. doi: 10.1007/s40291-019-0039 — View Citation
Garcia-Murillas I, Schiavon G, Weigelt B, Ng C, Hrebien S, Cutts RJ, Cheang M, Osin P, Nerurkar A, Kozarewa I, Garrido JA, Dowsett M, Reis-Filho JS, Smith IE, Turner NC. Mutation tracking in circulating tumor DNA predicts relapse in early breast cancer. S — View Citation
Olsson E, Winter C, George A, Chen Y, Howlin J, Tang MH, Dahlgren M, Schulz R, Grabau D, van Westen D, Fernö M, Ingvar C, Rose C, Bendahl PO, Rydén L, Borg Å, Gruvberger-Saal SK, Jernström H, Saal LH. Serial monitoring of circulating tumor DNA in patients — View Citation
Reinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S — View Citation
Rolfo C, Castiglia M, Hong D, Alessandro R, Mertens I, Baggerman G, Zwaenepoel K, Gil-Bazo I, Passiglia F, Carreca AP, Taverna S, Vento R, Santini D, Peeters M, Russo A, Pauwels P. Liquid biopsies in lung cancer: the new ambrosia of researchers. Biochim B — View Citation
Sausen M, Phallen J, Adleff V, Jones S, Leary RJ, Barrett MT, Anagnostou V, Parpart-Li S, Murphy D, Kay Li Q, Hruban CA, Scharpf R, White JR, O'Dwyer PJ, Allen PJ, Eshleman JR, Thompson CB, Klimstra DS, Linehan DC, Maitra A, Hruban RH, Diaz LA Jr, Von Hof — View Citation
Tie J, Cohen JD, Wang Y, Christie M, Simons K, Lee M, Wong R, Kosmider S, Ananda S, McKendrick J, Lee B, Cho JH, Faragher I, Jones IT, Ptak J, Schaeffer MJ, Silliman N, Dobbyn L, Li L, Tomasetti C, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circul — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 3-year DFS rate | DFS defined as the time from randomization to occurrence of any of the following events, whichever occurs first:
Locoregional recurrence or distant metastases as determined by an independent central radiology assessment. Occurrence of the second primary (same or other) cancer as determined by an independent central radiology assessment. Death from any cause. Loss to follow-up is censored. |
3 years | |
Secondary | ctDNA status | Change of Circulating tumor DNA (ctDNA) status (every 3 months) | Through study completion, up to 5 years | |
Secondary | TEAE | Occurrence of treatment emergent adverse event (TEAE) | Through study completion, up to 3 years | |
Secondary | IMP | Occurrence of dose reduction and discontinuation of IMP due to a TEAE | Through study completion, up to 3 years | |
Secondary | Overall survival | Follow-up of the patients will be conducted to analyze 3-year and 5-year overall survival | 3 years and 5 years |
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