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
|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|
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 Type :||Observational|
|Estimated Enrollment :||55 participants|
|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|
- Diagnostic Test: prospective single arm biomarker (plasma cell-free DNA hydroxymethylation) study
- clinically detectable recurrence at 1 year after surgery. [ Time Frame: 5 years ]
- Clear radiological evidence of recurrent disease.
- Histopathological proof (by means of endoscopy, imaging guided biopsy or diagnostic surgery) of recurrent disease.
- A new lesion revealed by physical examination
Biospecimen Retention: Samples With DNA
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
|United States, Illinois|
|The University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Shirley Rodriguez 773-834-4337 firstname.lastname@example.org|