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the Role of ctDNA in Predicting the Recurrence Risk of Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05131243
Recruitment Status : Not yet recruiting
First Posted : November 23, 2021
Last Update Posted : November 23, 2021
Sponsor:
Information provided by (Responsible Party):
Fujian Cancer Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Stage II Colorectal Cancer Stage III Procedure: Chemotherapy time Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

Arm Intervention/treatment
Experimental: ctDNA positive patients
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.
Procedure: Chemotherapy time
6 months of chemotherapy

Active Comparator: ctDNA negative patients
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.
Procedure: Chemotherapy time
3 months of chemotherapy




Primary Outcome Measures :
  1. ctDNA status [ Time Frame: Two weeks ]
    Detect postoperative tissue ctDNA status

  2. ctDNA dynamic detection [ Time Frame: 6 months ]
    ctDNA dynamic monitoring during postoperative adjuvant chemotherapy


Secondary Outcome Measures :
  1. Imaging examination [ Time Frame: 6 months ]
    Imaging examination during postoperative adjuvant chemotherapy

  2. Tumor Marker examination [ Time Frame: 6 months ]
    Tumor marker examination during postoperative adjuvant chemotherapy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05131243


Contacts
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Contact: Xiaojie Wang 13509399900 634793899@qq.com

Sponsors and Collaborators
Fujian Cancer Hospital
Publications:

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Responsible Party: Fujian Cancer Hospital
ClinicalTrials.gov Identifier: NCT05131243    
Other Study ID Numbers: FZ-CON-001
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fujian Cancer Hospital:
ctDNA
Adjuvant chemotherapy
Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes