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

Colorectal Cancer Stage III Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05131243
• Other study ID #: FZ-CON-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2021
• Source: Fujian Cancer Hospital
• Contact: Xiaojie Wang
• Phone: 13509399900
• Email: 634793899[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Patients with colorectal cancer diagnosed pathologically as stage ? and stage ?.

• 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.

Related Conditions & MeSH terms

• Colorectal Cancer Stage II
• Colorectal Cancer Stage III
• Colorectal Neoplasms
• Recurrence

Intervention

Procedure:
• Chemotherapy time
6 months of chemotherapy
• Chemotherapy time
3 months of chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

References & Publications (5)

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. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ctDNA status	Detect postoperative tissue ctDNA status	Two weeks
Primary	ctDNA dynamic detection	ctDNA dynamic monitoring during postoperative adjuvant chemotherapy	6 months
Secondary	Imaging examination	Imaging examination during postoperative adjuvant chemotherapy	6 months
Secondary	Tumor Marker examination	Tumor marker examination during postoperative adjuvant chemotherapy	6 months