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

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ClinicalTrials.gov Identifier: NCT05131243

Recruitment Status : Not yet recruiting

First Posted : November 23, 2021

Last Update Posted : November 23, 2021

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Fujian Cancer Hospital

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.

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.

Study Design

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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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

ctDNA status [ Time Frame: Two weeks ]
Detect postoperative tissue ctDNA status
ctDNA dynamic detection [ Time Frame: 6 months ]
ctDNA dynamic monitoring during postoperative adjuvant chemotherapy

Secondary Outcome Measures :

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

Eligibility Criteria

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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.

Contacts and Locations

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

More Information

Publications:

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.

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.

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.

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.

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.

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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

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