- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05068531
Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients (eDetect-mCRC)
A Prospective Observational Cohort Study for Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients Undergoing Systemic Chemotherapy and Liver Resection With Curative Intent
Study Overview
Status
Conditions
Detailed Description
The general objective of this single-centre, prospective observational cohort study in 100 mCRC-LR patients treated with curative intent along standard of care (SOC), is to obtain real-world data on administered therapies, selected complications, and oncological outcomes, while longitudinally collecting biospecimens to enable correlative research investigating early biological markers of treatment resistance and recurrence.
Cryopreservation of sequential blood derivatives, tumor tissue, and stool samples will allow investigation of circulating tumor DNA (ctDNA), T-cell receptor repertoire, somatic cancer mutations, immune and other gene expression, gut microbiome, and soluble factors.
The first biological marker that will be investigated in correlative research will be longitudinal measurements of ctDNA targeting 30 oncogenes, 23 axons, and 146 hotspots (Follow It assay, Canexia Health). Additional biological markers will be defined in subsequent amendments to this protocol.
The results are expected to provide important insights for the design of future trials investigating ways to personalize therapy, such as to: a) avoid the unnecessary use of neoadjuvant or adjuvant systemic chemotherapy, b) avoid morbid hepatectomies in patients unlikely to benefit, c) test novel preoperative therapies in patients more likely to benefit, and d) modulate the intensity of follow-up.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Wiam Belkaid, PhD
- Phone Number: 23242 514-890-8000
- Email: wiam.belkaid.chum@ssss.gouv.qc.ca
Study Locations
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Quebec
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Montreal, Quebec, Canada, H2X 3E4
- Recruiting
- Centre hospitalier de l'Université de Montréal (CHUM)
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Contact:
- Wiam Belkaid, PhD
- Phone Number: 23242 514-836-3273
- Email: wiam.belkaid.chum@ssss.gouv.qc.ca
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Principal Investigator:
- Simon Turcotte, MD,MSc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female patients (≥18 years of age at the time of consent);
- Stage IV colon or rectal adenocarcinoma with liver-restricted metastasis(es) for whom partial hepatectomy with curative intent is planned;
- Instead of, or in addition to, partial hepatectomy, liver metastases may be ablated by needle radio frequency or microwave; in case of a solitary liver metastasis, three core-needle biopsies are provided for research at time of the procedure and prior to tissue destruction;
- Patients may undergo planned two-stage partial hepatectomies;
- Patients may have at baseline lung micro nodules or intra-abdominal enlarged nodes or nodules of unknown nature, not considered as extra-hepatic metastases in the opinion of the investigator;
- Patients who are scheduled to receive FOLFOX-based pre-hepatectomy may receive any additional combined agents, such as and not limited to Irinotecan, anti-EGFR, and anti-VEGF drugs;
- Patients are willing and able to provide serial blood samples, tumor and adjacent tissues, and stool samples for research;
- The timing and specific treatments of the primary colon or rectal tumor is per SOC, at the discretion of the treating physician, including the use of pre-operative radiotherapy for rectal cancer;
- Patients may receive post-operative adjuvant chemotherapy per SOC, at the discretion of the treating physician;
- Patients must consent to the Exactis Personalized my Treatment registry.
Exclusion Criteria:
- Pregnant or breastfeeding patients,
- Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome), and
- Presence of concurrent other cancer(s).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Observational
We plan to recruit up to 100 mCRC patients with baseline resectable liver-restricted metastases (mCRC-LR) without evidence of extra-hepatic metastases, with primary tumor already or to be resected (metachronous or synchronous disease), planned to receive upfront FOLFOX-based preoperative neoadjuvant systemic chemotherapy, who achieved no-evidence of disease (NED) in the abdomen by standard imaging.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiological response to pre-operative chemotherapy as assessed by RECIST v1.1
Time Frame: Approximately three months
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Approximately three months
|
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Biochemical response to pre-operative chemotherapy as assessed by plasmatic CEA measurement, change from baseline after 4 cycles of chemotherapy
Time Frame: Approximately three months
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Approximately three months
|
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Pathological response to pre-operative chemotherapy as assessed by Ryan and Rubbia Brandt Tumor Regression Grade (TRG) scores on resected tumors
Time Frame: Approximately three months
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Approximately three months
|
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Tumor response to pre-operative chemotherapy as assessed by change in circulating tumor DNA level, change from baseline
Time Frame: Approximately three months
|
Follow It assay, Canexia Health
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Approximately three months
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Histopathologic growth pattern as assessed by percent replacement, desmoplastic, and pushing features measured at the interface of liver metastasis and non tumoral liver
Time Frame: Three to four months
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Three to four months
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Post-operative minimal residual disease as assessed by circulating tumor DNA detection after tumor resection with curative intent
Time Frame: Approximately 1 months after resection with curative intent
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Follow It assay, Canexia Health
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Approximately 1 months after resection with curative intent
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Time to radiological recurrence after tumor resection with curative intent
Time Frame: Up to three years after tumor resection with curative intent
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Up to three years after tumor resection with curative intent
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Time to biochemical recurrence as assessed by plasmatic CEA measurement, level above the upper limit occurring after tumor resection with curative intent
Time Frame: Up to three years after tumor resection with curative intent
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Up to three years after tumor resection with curative intent
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Time to tumor recurrence as assessed by detection or change in level of circulating tumor DNA after tumor resection with curative intent
Time Frame: Up to three years after tumor resection with curative intent
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Follow It assay, Canexia Health
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Up to three years after tumor resection with curative intent
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence and grade of FOLFOX-induced neuropathy, as assessed by Sensory Subscale of the NCI CTCAE scale, version 3
Time Frame: Two to three months pre-operatively and during post-operative adjuvant chemotherapy
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Two to three months pre-operatively and during post-operative adjuvant chemotherapy
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Incidence of allergic reaction to oxaliplatin diagnosed by treating physicians and requiring desensitization or change in chemotherapy regimen
Time Frame: Two to three months pre-operatively and during post-operative adjuvant chemotherapy
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Two to three months pre-operatively and during post-operative adjuvant chemotherapy
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Incidence of hospitalization for febrile neutropenia diagnosed by treating physicians
Time Frame: Two to three months pre-operatively and during post-operative adjuvant chemotherapy
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Two to three months pre-operatively and during post-operative adjuvant chemotherapy
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Ninety-day post-surgical complications, defined by Clavien Dindo grading system
Time Frame: 90 days after tumor resection
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90 days after tumor resection
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Disease-specific survival after complete tumor resection
Time Frame: Up to three years after tumor resection with curative intent
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Up to three years after tumor resection with curative intent
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Simon Turcotte, MD, MSc, CHUM
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21.103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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