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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
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Stage II focused on measuring ctDNA, Adjuvant chemotherapy, Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 11, 2021
    Last Updated
    November 11, 2021
    Sponsor
    Fujian Cancer Hospital
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    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
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    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
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    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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