Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT04157322
Study type Observational
Source University of Chicago
Contact
Status Active, not recruiting
Phase
Start date August 26, 2019
Completion date October 31, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT03941080 - Gut Microbiome Dynamics in Metastasized or Irresectable Colorectal Cancer
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Completed NCT03647839 - Modulation Of The Tumour Microenvironment Using Either Vascular Disrupting Agents or STAT3 Inhibition in Order to Synergise With PD1 Inhibition in Microsatellite Stable, Refractory Colorectal Cancer Phase 2
Recruiting NCT05057052 - Cryoablation Combined With Sintilimab Plus Regorafenib In Previously Treated Colorectal Cancer Liver Metastasis Phase 2
Terminated NCT02316496 - Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study Phase 2
Completed NCT03251612 - Predictive Value of Drug Sensitivity Testing Tumorspheres From Patients With Metastatic Colorectal Cancer Phase 2
Completed NCT02380443 - AlloStim® Immunotherapy Dosing Alone or in Combination With Cryoablation in Metastatic Colorectal Cancer Phase 2
Recruiting NCT02149784 - Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients Phase 3
Recruiting NCT01959061 - Efficacy and Safety of Raltitrexed-based Transarterial Chemoembolisation(TACE)for Colorectal Cancer Liver Metastases Phase 4
Terminated NCT01668680 - Maintenance Metronomic Chemotherapy for Metastatic Colorectal Carcinoma Phase 2
Recruiting NCT05068531 - Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
Not yet recruiting NCT04525807 - Precision Medicine for Colorectal Cancer Liver Metastasis Guided by Multi-omics Data Under the Umbrella Theory
Completed NCT04482608 - The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival
Recruiting NCT03193710 - The Effects of General Anesthetics on Lymphocytes in Patients Undergoing Colorectal Cancer Resection and Mechanism Involved N/A
Recruiting NCT04854213 - PRELUDE-1 (Prospective Evaluation of Radiotherapy-induced Biologic Effects in Colorectal Cancer Oligometastatic Patients With LUng-limited Disease: Evolution of Cancer Genetics and Regulatory Immune Cells) N/A
Suspended NCT04108481 - Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer Phase 1/Phase 2
Completed NCT03142516 - FOLFIRI + Panitumumab First-line Treatment in Elderly Patients With Unresectable Metastatic Colorectal Cancer, RAS/BRAF Wild-type and Good Performance Status Phase 2
Completed NCT03144804 - A Phase 2 Study of Lamivudine in Patients With p53 Mutant Metastatic Colorectal Cancer Phase 2
Active, not recruiting NCT01910610 - Multi-Line Therapy Trial in Unresectable Metastatic Colorectal Cancer Phase 3
Recruiting NCT05759728 - A Study of CNA3103 (LGR5-targeted, Autologous CAR-T Cells) Administered to Subjects With Metastatic Colorectal Cancer Phase 1/Phase 2