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Status unknownNCT05131243Updated Nov 23, 2021

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

An interventional study of Chemotherapy time and Chemotherapy time in Colorectal Cancer Stage II and Colorectal Cancer Stage III, sponsored by Fujian Cancer Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.

Sponsored by Fujian Cancer Hospital · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Nov 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Colorectal Cancer Stage II
  • Colorectal Cancer Stage III

Keywords

  • ctDNA
  • Adjuvant chemotherapy
  • Colorectal Cancer
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In context

Colorectal Neoplasms

5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.

This study's planned enrollment of 100 is above the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 162 studies on the registry; 92 are open to participants now.

Browse Fujian Cancer Hospital studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureChemotherapy time

    6 months of chemotherapy

  • ProcedureChemotherapy time

    3 months of chemotherapy

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What researchers measure

Primary outcomes

  1. ctDNA status

    Detect postoperative tissue ctDNA status

    Time frame: Two weeks

  2. ctDNA dynamic detection

    ctDNA dynamic monitoring during postoperative adjuvant chemotherapy

    Time frame: 6 months

Secondary outcomes

  1. Imaging examination

    Imaging examination during postoperative adjuvant chemotherapy

    Time frame: 6 months

  2. Tumor Marker examination

    Tumor marker examination during postoperative adjuvant chemotherapy

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 26101870 ↗
  • 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. PubMed 18670422 ↗
  • 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. PubMed 23484797 ↗
  • 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. PubMed 26311728 ↗
  • 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. PubMed 27384348 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05131243
Lead sponsor
Fujian Cancer Hospital
Responsible party
Sponsor
First posted
Nov 23, 2021
Start date
Dec 1, 2021 (estimated)
Primary completion
May 1, 2023 (estimated)
Completion
May 1, 2023 (estimated)
Last update
Nov 23, 2021

Study contacts

Xiaojie Wang
Contact
634793899@qq.com
13509399900

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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