the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer
Primary Purpose
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chemotherapy time
Chemotherapy time
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer Stage II focused on measuring ctDNA, Adjuvant chemotherapy, Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 1. Patients with colorectal cancer diagnosed pathologically as stage Ⅱ and stage Ⅲ.
- 2. The patient underwent radical surgical treatment.
- 3. 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).
- 4. The patient understands and is willing to sign a written informed consent document.
- 5. During the treatment process, the patient can cooperate to provide samples of each node.
- 6. The patient can provide corresponding clinical materials, including but not limited to case diagnosis, imaging evaluation, and serum protein marker test results.
Exclusion Criteria:
- 1. The patient cannot provide a complete and qualified specimen.
- 2. The patient has other primary malignant tumors or serious medical illnesses.
- 3. The patient cannot cooperate with the follow-up.
- 4. Conditions that other researchers deemed inappropriate for continuing to participate in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ctDNA positive patients
ctDNA negative patients
Arm Description
Postoperative 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.
Postoperative 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.
Outcomes
Primary Outcome Measures
ctDNA status
Detect postoperative tissue ctDNA status
ctDNA dynamic detection
ctDNA dynamic monitoring during postoperative adjuvant chemotherapy
Secondary Outcome Measures
Imaging examination
Imaging examination during postoperative adjuvant chemotherapy
Tumor Marker examination
Tumor marker examination during postoperative adjuvant chemotherapy
Full Information
NCT ID
NCT05131243
First Posted
November 11, 2021
Last Updated
November 11, 2021
Sponsor
Fujian Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05131243
Brief Title
the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer
Official Title
the Role of ctDNA in Predicting the Recurrence Risk of Stage Ⅱ and Ⅲ Colorectal Cancer and the Dynamic Changes in ctDNA of Patients With Adjuvant Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
In this clinical study, ctDNA will be detected in postoperative patients with stage Ⅱ and Ⅲ colorectal cancer to evaluate the correlation between ctDNA and the risk of postoperative recurrence. According to the dynamic changes of ctDNA after adjuvant chemotherapy, the correlation between ctDNA and postoperative DFS will be compared, and the feasibility of ctDNA as a molecular marker to evaluate the risk of postoperative recurrence of colorectal cancer will be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Keywords
ctDNA, Adjuvant chemotherapy, Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ctDNA positive patients
Arm Type
Experimental
Arm Description
Postoperative 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.
Arm Title
ctDNA negative patients
Arm Type
Active Comparator
Arm Description
Postoperative 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.
Intervention Type
Procedure
Intervention Name(s)
Chemotherapy time
Intervention Description
6 months of chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Chemotherapy time
Intervention Description
3 months of chemotherapy
Primary Outcome Measure Information:
Title
ctDNA status
Description
Detect postoperative tissue ctDNA status
Time Frame
Two weeks
Title
ctDNA dynamic detection
Description
ctDNA dynamic monitoring during postoperative adjuvant chemotherapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Imaging examination
Description
Imaging examination during postoperative adjuvant chemotherapy
Time Frame
6 months
Title
Tumor Marker examination
Description
Tumor marker examination during postoperative adjuvant chemotherapy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patients with colorectal cancer diagnosed pathologically as stage Ⅱ and stage Ⅲ.
2. The patient underwent radical surgical treatment.
3. 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).
4. The patient understands and is willing to sign a written informed consent document.
5. During the treatment process, the patient can cooperate to provide samples of each node.
6. The patient can provide corresponding clinical materials, including but not limited to case diagnosis, imaging evaluation, and serum protein marker test results.
Exclusion Criteria:
1. The patient cannot provide a complete and qualified specimen.
2. The patient has other primary malignant tumors or serious medical illnesses.
3. The patient cannot cooperate with the follow-up.
4. Conditions that other researchers deemed inappropriate for continuing to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojie Wang
Phone
13509399900
Email
634793899@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26101870
Citation
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.
Results Reference
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PubMed Identifier
18670422
Citation
Diehl 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.
Results Reference
background
PubMed Identifier
23484797
Citation
Dawson 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.
Results Reference
background
PubMed Identifier
26311728
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. Sci Transl Med. 2015 Aug 26;7(302):302ra133. doi: 10.1126/scitranslmed.aab0021.
Results Reference
background
PubMed Identifier
27384348
Citation
Tie 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.
Results Reference
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the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer
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