Clinical trial · Observational
MRD Test in Common Risk Stage II Colorectal Cancer
Observation of MRD Detection for Preoperative Sensitivity and Postoperative Positive Rate in Common Risk Stage II Colorectal Cancer
NCT05795010CI-TRIAL-00065250HuaMC-1unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients with colorectal cancer who were confirmed as stage II general risk type in the postoperative pathological report began to be enrolled. Observe the sensitivity of the detection of micro-MRD before operation and the postoperative positive rate of this type of patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage II Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRD test | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Positive rate of preoperative MRD test
- timeFrame
- six months
- description
- To observe the positive rate of preoperative MRD detection for stage II colorectal cancer
Secondary outcomes (1)
- measure
- Positive rate of MRD test 1 month and 3 months after operation
- timeFrame
- nine months
- description
- Observe the positive rate of MRD detection at 1 month and 3 months after operation for stage II colorectal cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-75; * Pathologically confirmed rectal adenocarcinoma; * Pathological differentiation is highly or moderately differentiated; * The pathological stage was pT3N0, that is, invasion of the proper muscular layer of the intestinal wall without lymph node metastasis; * No new adjuvant treatment before operation * There was no vascular infiltration and nerve infiltration in postoperative pathology; * No preoperative intestinal obstruction or tumor site perforation; * No postoperative pathological margin was positive or unknown; * The distance between the pathological cutting edge and the tumor was more than 1 cm; * Invasion of mesentery of intestinal wall ≤ 2mm; * More than 12 lymph nodes were submitted for examination; * Nonlocal recurrence and distant metastasis; * No multiple primary carcinoma of colon and rectum; * Physical condition score PS ≤ 2 points; * Patients and their families can understand and are willing to participate in this study and provide written informed consent. Exclusion Criteria: * Multiple intestinal carcinomatosis * Previous history of malignant tumor, * There are concurrent malignant tumors in the whole body except for colorectal cancer * Colorectal cancer with preoperative anti-tumor treatment * Pregnant or lactating women * There are serious complications during or after operation, affecting the prognosis * Hepatitis B or Hepatitis C antibody positive * HIV antibody positive * Other diseases considered by the research doctor to affect the prognosis and survival * Other conditions that the research doctor believes are not consistent with this study.
References
Publications (3)
- BACKGROUNDReinert T, Henriksen TV, Christensen E, Sharma S, Salari R, Sethi H, Knudsen M, Nordentoft I, Wu HT, Tin AS, Heilskov Rasmussen M, Vang S, Shchegrova S, Frydendahl Boll Johansen A, Srinivasan R, Assaf Z, Balcioglu M, Olson A, Dashner S, Hafez D, Navarro S, Goel S, Rabinowitz M, Billings P, Sigurjonsson S, Dyrskjot L, Swenerton R, Aleshin A, Laurberg S, Husted Madsen A, Kannerup AS, Stribolt K, Palmelund Krag S, Iversen LH, Gotschalck Sunesen K, Lin CJ, Zimmermann BG, Lindbjerg Andersen C. Analysis of Plasma Cell-Free DNA by Ultradeep Sequencing in Patients With Stages I to III Colorectal Cancer. JAMA Oncol. 2019 Aug 1;5(8):1124-1131. doi: 10.1001/jamaoncol.2019.0528. PMID 31070691
- BACKGROUNDRomero D. ctDNA guides omission of adjuvant chemotherapy for stage II CRC. Nat Rev Clin Oncol. 2022 Aug;19(8):493. doi: 10.1038/s41571-022-00657-7. No abstract available. PMID 35750857
- RESULTTie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S, Wong R, Shapiro J, Lee M, Harris S, Khattak A, Burge M, Harris M, Lynam J, Nott L, Day F, Hayes T, McLachlan SA, Lee B, Ptak J, Silliman N, Dobbyn L, Popoli M, Hruban R, Lennon AM, Papadopoulos N, Kinzler KW, Vogelstein B, Tomasetti C, Gibbs P; DYNAMIC Investigators. Circulating Tumor DNA Analysis Guiding Adjuvant Therapy in Stage II Colon Cancer. N Engl J Med. 2022 Jun 16;386(24):2261-2272. doi: 10.1056/NEJMoa2200075. Epub 2022 Jun 4. PMID 35657320