Clinical trial · Observational
Plasma 5hmC Signatures as a Marker of Colorectal / Appendiceal Peritoneal Metastasis
5-hydroxymethylation Signatures in Plasma Circulating Cell-free DNA as Markers for Tumor Burden and Recurrence in Appendiceal and Colorectal Peritoneal Metastasis
- 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 peritoneal metastasis of colorectal or high grade appendiceal origin who are candidates for cytoreductive surgery with HIPEC (hyperthermic intraperitoneal chemotherapy) will be enrolled in this study. Blood collection for measurements of plasma cell-free DNA hydroxymethylation signatures will be performed at different time points, before and after surgery, in order to determine if plasma hydroxymethylation signatures are more sensitive than conventional tumor markers in identifying clinically detectable recurrence at 1 year after surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Appendix Cancer | Malignant Appendix Neoplasm | ALIAS | 0.90 |
| Colorectal Cancer, Genetics of | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
| Colorectal Cancer Stage IV | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prospective single arm biomarker (plasma cell-free DNA hydroxymethylation) study | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- clinically detectable recurrence at 1 year after surgery.
- timeFrame
- 5 years
- description
- 1. Clear radiological evidence of recurrent disease. 2. Histopathological proof (by means of endoscopy, imaging guided biopsy or diagnostic surgery) of recurrent disease. 3. A new lesion revealed by physical examination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: I. Histologic proof of colorectal adenocarcinoma or high grade appendiceal tumors (appendiceal adenocarcinoma or ex-goblet adenocarcinoma Tang B or C). II. Age ≥ 18 years. III. Patients with known peritoneal metastasis (PM) who are candidates for complete cytoreduction and HIPEC. Known PM - diagnosed previously by diagnostic laparoscopy / laparotomy or clear radiological evidence of PM. IV. Neoadjuvant chemotherapy permitted. V. The patient is able to provide informed consent. VI. The patient is planned to undergo his / her postoperative surveillance at UCM, as this study's protocol requires multiple clinic visits. VII. No evidence of systemic metastasis. \- Exclusion Criteria: Vulnerable subjects will not participate in this study.
References
Publications (0)
Data not yet available