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

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ClinicalTrials.gov Identifier: NCT04157322
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Colorectal Cancer Stage IV Colorectal Cancer Metastatic Colorectal Cancer, Genetics of Appendix Cancer Diagnostic Test: prospective single arm biomarker (plasma cell-free DNA hydroxymethylation) study

Detailed Description:

This will be a prospective single arm biomarker (plasma-free DNA 5-hydroxymethylation) study. Fifty-five Adult patients with peritoneal metastases of colorectal and appendiceal origin who are candidates for a curative surgery and fulfill the inclusion criteria will be offered to participate in this study. In addition to the postoperative standard of care oncological surveillance of these patients which includes periodic physical examinations, cross sectional imaging studies (CT or MRI) and blood work for conventional tumor markers, serial measurements of plasma hydroxymethylation signatures will be performed. We will use a model developed in a separate pilot study to identify recurrent peritoneal metastasis based on 5hmC signatures. As part of this study, blood collection for measurements of plasma hydroxymethylation signatures of target genes will be performed at seven time points:

  • Just before surgery (During the preoperative clinic visit or at the operating room).
  • 5-7 days after surgery (just before hospital discharge).
  • 6 weeks after surgery (first postoperative clinic visit).
  • 3 months after surgery (second postoperative clinic visit).
  • 6 months after surgery (third postoperative clinic visit).
  • 9 months after surgery (fourth postoperative clinic visit).
  • 12 months after surgery (fifth postoperative clinic visit). Standard of care surveillance elements that include patient history and physical examination, conventional blood biomarkers (CEA, CA 19-9 and CA 125) and cross sectional imaging of the chest, abdomen and pelvis will be undertaken simultaneously at similar time points. We will then compare the sensitivities of DNA hydroxymethylation signatures and conventional blood biomarkers in diagnosing clinically detectable recurrence at 1 year after surgery. We hypothesize that plasma hydroxymethylation signatures have higher sensitivity in identifying clinically detectable recurrence when compared with conventional tumor markers (CEA, CA 19-9 and CA 125).

Study Design
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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 5-hydroxymethylation Signatures in Plasma Circulating Cell-free DNA as Markers for Tumor Burden and Recurrence in Appendiceal and Colorectal Peritoneal Metastasis
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2025
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: prospective single arm biomarker (plasma cell-free DNA hydroxymethylation) study
    Blood draw

Outcome Measures
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Primary Outcome Measures :
  1. clinically detectable recurrence at 1 year after surgery. [ Time Frame: 5 years ]
    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


Biospecimen Retention:   Samples With DNA
Plasma samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with peritoneal metastasis of colorectal or high grade appendiceal origin who are candidates for cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157322


Locations
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United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Shirley Rodriguez    773-834-4337    srodrigu@surgery.bsd.uchicago.edu   
Sponsors and Collaborators
University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04157322     History of Changes
Other Study ID Numbers: IRB19-0913
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Appendiceal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cecal Neoplasms
Cecal Diseases