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NCT04157322
Plasma 5hmC Signatures as a Marker of Colorectal / Appendiceal Peritoneal Metastasis
trial testing prospective single arm biomarker (plasma cell-free DNA hydroxymethylation) study in Colorectal Cancer Stage IV in 55 participants. Participants enrolled and being followed up; not accepting new ones.
31 October 2027
Quick facts
| Lead sponsor | University of Chicago |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 55 |
| Start date | 26 August 2019 |
| Primary completion | 31 October 2027 |
| Estimated completion | 31 October 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- prospective single arm biomarker (plasma cell-free DNA hydroxymethylation) study
Conditions studied
- Colorectal Cancer Stage IV — all drugs for Colorectal Cancer Stage IV →
- Colorectal Cancer Metastatic — all drugs for Colorectal Cancer Metastatic →
- Colorectal Cancer, Genetics of — all drugs for Colorectal Cancer, Genetics of →
- Appendix Cancer — all drugs for Appendix Cancer →
Sponsor
University of Chicago
Who can join
18 and older, any sex, with Colorectal Cancer Stage IV or Colorectal Cancer Metastatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Exploring the clinical utility of liquid biopsy with cfDNA in cancer: A systematic review.
Ranganathan K, Kurian NS, Goswami HM, Rishi KD, et al · · 2024 · cited 5× · PMID 40027943 · DOI 10.1016/j.jlb.2024.100150
Verify or expand the search:
- PubMed search for NCT04157322
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Chicago trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04157322 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Chicago
- Last refreshed: 3 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04157322.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing