the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer
1 other identifier
interventional
100
0 countries
N/A
Brief Summary
The purpose of this study was to observe the relationship between ctDNA as a molecular marker of colorectal cancer and the risk of postoperative recurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2021
CompletedFirst Posted
Study publicly available on registry
November 23, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2023
CompletedNovember 23, 2021
November 1, 2021
1.4 years
November 11, 2021
November 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ctDNA status
Detect postoperative tissue ctDNA status
Two weeks
ctDNA dynamic detection
ctDNA dynamic monitoring during postoperative adjuvant chemotherapy
6 months
Secondary Outcomes (2)
Imaging examination
6 months
Tumor Marker examination
6 months
Study Arms (2)
ctDNA positive patients
EXPERIMENTALPostoperative ctDNA-positive patients will receive chemotherapy for 6 months.The ctDNA dynamic detection and imaging examination will be completed every 3 months, and tumor markers will be detected in each chemotherapy cycle.
ctDNA negative patients
ACTIVE COMPARATORPostoperative ctDNA-negative patients will receive chemotherapy for 3 months. The ctDNA dynamic detection and imaging examination will be completed every 3 months, and tumor markers will be detected in each chemotherapy cycle.
Interventions
Eligibility Criteria
You may qualify if:
- \. Patients with colorectal cancer diagnosed pathologically as stage Ⅱ and stage Ⅲ.
- \. The patient underwent radical surgical treatment.
- \. The patient has the results of genetic genetic testing for gastrointestinal tumors, including the genetic mutation status of MMR genes and related genes (MLH1, MSH2, MSH6, PMS2, MLH3, EPCAM).
- \. The patient understands and is willing to sign a written informed consent document.
- \. During the treatment process, the patient can cooperate to provide samples of each node.
- \. The patient can provide corresponding clinical materials, including but not limited to case diagnosis, imaging evaluation, and serum protein marker test results.
You may not qualify if:
- \. The patient cannot provide a complete and qualified specimen.
- \. The patient has other primary malignant tumors or serious medical illnesses.
- \. The patient cannot cooperate with the follow-up.
- \. Conditions that other researchers deemed inappropriate for continuing to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Francis G, Stein S. Circulating Cell-Free Tumour DNA in the Management of Cancer. Int J Mol Sci. 2015 Jun 19;16(6):14122-42. doi: 10.3390/ijms160614122.
PMID: 26101870BACKGROUNDDiehl F, Schmidt K, Choti MA, Romans K, Goodman S, Li M, Thornton K, Agrawal N, Sokoll L, Szabo SA, Kinzler KW, Vogelstein B, Diaz LA Jr. Circulating mutant DNA to assess tumor dynamics. Nat Med. 2008 Sep;14(9):985-90. doi: 10.1038/nm.1789. Epub 2007 Jul 31.
PMID: 18670422BACKGROUNDDawson SJ, Tsui DW, Murtaza M, Biggs H, Rueda OM, Chin SF, Dunning MJ, Gale D, Forshew T, Mahler-Araujo B, Rajan S, Humphray S, Becq J, Halsall D, Wallis M, Bentley D, Caldas C, Rosenfeld N. Analysis of circulating tumor DNA to monitor metastatic breast cancer. N Engl J Med. 2013 Mar 28;368(13):1199-209. doi: 10.1056/NEJMoa1213261. Epub 2013 Mar 13.
PMID: 23484797BACKGROUNDGarcia-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. Sci Transl Med. 2015 Aug 26;7(302):302ra133. doi: 10.1126/scitranslmed.aab0021.
PMID: 26311728BACKGROUNDTie J, Wang Y, Tomasetti C, Li L, Springer S, Kinde I, Silliman N, Tacey M, Wong HL, Christie M, Kosmider S, Skinner I, Wong R, Steel M, Tran B, Desai J, Jones I, Haydon A, Hayes T, Price TJ, Strausberg RL, Diaz LA Jr, Papadopoulos N, Kinzler KW, Vogelstein B, Gibbs P. Circulating tumor DNA analysis detects minimal residual disease and predicts recurrence in patients with stage II colon cancer. Sci Transl Med. 2016 Jul 6;8(346):346ra92. doi: 10.1126/scitranslmed.aaf6219.
PMID: 27384348BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2021
First Posted
November 23, 2021
Study Start
December 1, 2021
Primary Completion
May 1, 2023
Study Completion
May 1, 2023
Last Updated
November 23, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share