Clinical trial · Interventional
ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer
Circulating Tumor DNA (ctDNA) as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer: A Prospective, Open-label, Randomized Controlled Study
NCT04752930CI-TRIAL-00050043unknownN/AClinicalTrials.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)
This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Peritoneal Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ctDNA monitoring | Diagnostic Test | — | UNRESOLVED |
| Imageology | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ctDNA monitoring
- description
- ctDNA monitoring will be performed at protocol-specified intervals and requirement
- interventionNames
- Diagnostic Test: ctDNA monitoring
- type
- ACTIVE_COMPARATOR
- label
- Imageology (SOC)
- description
- Imaging examination will be performed at protocol-specified intervals and requirement
- interventionNames
- Diagnostic Test: Imageology
Primary outcomes (1)
- measure
- Peritoneal Metastasis Free Survival (PMFS)
- timeFrame
- Through study completion, up to 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be a man or woman of at 18-75; * Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-21； * Patients with primary colorectal cancer proven by pathology； * Patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, PT4, CT4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of PT3, positive surgical margin, and tumor rupture and hemorrhage); * 6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctDNA tests within one month; * Patients who have finished standard adjuvant therapy after surgery; (Choose 5-FU or 5-FU analog-based chemotherapy regimen, and the perioperative chemotherapy should not exceed 6 months)； * Patients who are negative of recurrence or metastasis in conventional oncology examination (serology, endoscopy, imaging) ; * Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study. Exclusion Criteria: * Patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer; * ASA class Ⅳ to Ⅴ; * Patients who have other existence of distant metastasis outside the abdomen; * Patients with serious mental illness; * Patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases; * Patients who cannot be followed up as scheduled; * Patients who participated in other clinical studies within 3 months prior to the trial; * Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.
References
Publications (18)
- BACKGROUNDFranko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12. PMID 22162570
- BACKGROUNDYonemura Y, Bandou E, Kawamura T, Endou Y, Sasaki T. Quantitative prognostic indicators of peritoneal dissemination of gastric cancer. Eur J Surg Oncol. 2006 Aug;32(6):602-6. doi: 10.1016/j.ejso.2006.03.003. Epub 2006 Apr 17. PMID 16617004
- BACKGROUNDElias D, Lefevre JH, Chevalier J, Brouquet A, Marchal F, Classe JM, Ferron G, Guilloit JM, Meeus P, Goere D, Bonastre J. Complete cytoreductive surgery plus intraperitoneal chemohyperthermia with oxaliplatin for peritoneal carcinomatosis of colorectal origin. J Clin Oncol. 2009 Feb 10;27(5):681-5. doi: 10.1200/JCO.2008.19.7160. Epub 2008 Dec 22. PMID 19103728
- BACKGROUNDBaratti D, Kusamura S, Deraco M. The Fifth International Workshop on Peritoneal Surface Malignancy (Milan, Italy, December 4-6, 2006): methodology of disease-specific consensus. J Surg Oncol. 2008 Sep 15;98(4):258-62. doi: 10.1002/jso.21056. PMID 18726888
- BACKGROUNDEsquivel J, Chua TC, Stojadinovic A, Melero JT, Levine EA, Gutman M, Howard R, Piso P, Nissan A, Gomez-Portilla A, Gonzalez-Bayon L, Gonzalez-Moreno S, Shen P, Stewart JH, Sugarbaker PH, Barone RM, Hoefer R, Morris DL, Sardi A, Sticca RP. Accuracy and clinical relevance of computed tomography scan interpretation of peritoneal cancer index in colorectal cancer peritoneal carcinomatosis: a multi-institutional study. J Surg Oncol. 2010 Nov 1;102(6):565-70. doi: 10.1002/jso.21601. PMID 20976729
- BACKGROUNDDromain C, Leboulleux S, Auperin A, Goere D, Malka D, Lumbroso J, Schumberger M, Sigal R, Elias D. Staging of peritoneal carcinomatosis: enhanced CT vs. PET/CT. Abdom Imaging. 2008 Jan-Feb;33(1):87-93. doi: 10.1007/s00261-007-9211-7.