Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients (eDetect-mCRC)
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ClinicalTrials.gov Identifier: NCT05068531 |
Recruitment Status :
Recruiting
First Posted : October 6, 2021
Last Update Posted : April 18, 2024
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Condition or disease |
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Colorectal Cancer Metastatic |
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 : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Actual Study Start Date : | September 1, 2022 |
Estimated Primary Completion Date : | October 2026 |
Estimated Study Completion Date : | October 2026 |
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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- Radiological response to pre-operative chemotherapy as assessed by RECIST v1.1 [ Time Frame: Approximately three months ]
- 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 ]
- 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 ]
- 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
- 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 ]
- 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 ]Follow It assay, Canexia Health
- Time to radiological recurrence after tumor resection with curative intent [ Time Frame: Up to three years after tumor resection with curative intent ]
- 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 ]
- 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 ]Follow It assay, Canexia Health
- 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 ]
- 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 ]
- Incidence of hospitalization for febrile neutropenia diagnosed by treating physicians [ Time Frame: Two to three months pre-operatively and during post-operative adjuvant chemotherapy ]
- Ninety-day post-surgical complications, defined by Clavien Dindo grading system [ Time Frame: 90 days after tumor resection ]
- Disease-specific survival after complete tumor resection [ Time Frame: Up to three years after tumor resection with curative intent ]
Biospecimen Retention: Samples With DNA
- Serial blood samples processed to obtain plasma for ctDNA and soluble factor research, buffy coat for genomic research, and mononuclear cells for live cells immune assays;
- Tumor samples processed to allow genomic, proteomic and live cell research;
- Adjacent non-tumoral tissue to allow genomic, proteomic and live cell research;
- Stool samples at baseline and post neoadjuvant chemotherapy to allow metagenomics research.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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).
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): NCT05068531
Contact: Wiam Belkaid, PhD | 514-890-8000 ext 23242 | wiam.belkaid.chum@ssss.gouv.qc.ca |
Canada, Quebec | |
Centre hospitalier de l'Université de Montréal (CHUM) | Recruiting |
Montreal, Quebec, Canada, H2X 3E4 | |
Contact: Wiam Belkaid, PhD 514-836-3273 ext 23242 wiam.belkaid.chum@ssss.gouv.qc.ca | |
Principal Investigator: Simon Turcotte, MD,MSc |
Principal Investigator: | Simon Turcotte, MD, MSc | CHUM |
Responsible Party: | Centre hospitalier de l'Université de Montréal (CHUM) |
ClinicalTrials.gov Identifier: | NCT05068531 |
Other Study ID Numbers: |
21.103 |
First Posted: | October 6, 2021 Key Record Dates |
Last Update Posted: | April 18, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Real world data Observational study Circulating tumor DNA Microbiome |
Tumor immunology Metastatic colorectal cancer Liver metastasis Biomarker |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |