Active — Not RecruitingNot Applicable

Plasma 5hmC Signatures as a Marker of Colorectal / Appendiceal Peritoneal Metastasis

United States55 participantsStarted 2019-08-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

clinically detectable recurrence at 1 year after surgery.

Timeframe: 5 years

Trial details

NCT IDNCT04157322

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10-31