Colorectal Cancer MetastaticeDetect-mCRCNCT05068531
Early Detection of Treatment Failure in Metastatic Colorectal Cancer Patients
An observational study of Colorectal Cancer Metastatic, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
In North America, colorectal cancer patients with resectable liver-restricted metastases (mCRC-LR) are treated with approximately 6 months of preoperative systemic multi-agent chemotherapy. Actuarial data however supports that approximately 20% of mCRC-LR patients can be cured without as much systemic chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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;
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- 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.
Who cannot join
- Pregnant or breastfeeding patients,
- Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome), and
- Presence of concurrent other cancer(s).
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Wiam Belkaid, PhD, 514-836-3273 ext. 23242, wiam.belkaid.chum@ssss.gouv.qc.ca
Simon Turcotte, MD,MSc
About this study
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
In North America, colorectal cancer patients with resectable liver-restricted metastases (mCRC-LR) are treated with approximately 6 months of preoperative systemic multi-agent chemotherapy. Actuarial data however supports that approximately 20% of mCRC-LR patients can be cured without as much systemic chemotherapy. Prospective phase II-III trials also support that awaiting recurrence to initiate further metastases-targeted or systemic treatment may provide patients with longer overall survival while avoiding toxicities in those without recurrence.
Read the 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.
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Real world data, Observational study, Circulating tumor DNA, Microbiome, Tumor immunology, Metastatic colorectal cancer, Liver metastasis, Biomarker
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological response to pre-operative chemotherapy as assessed by RECIST v1.1
Measured: Approximately three months
Biochemical response to pre-operative chemotherapy as assessed by plasmatic CEA measurement, change from baseline after 4 cycles of chemotherapy
Measured: Approximately three months
Pathological response to pre-operative chemotherapy as assessed by Ryan and Rubbia Brandt Tumor Regression Grade (TRG) scores on resected tumors
Measured: Approximately three months
Tumor response to pre-operative chemotherapy as assessed by change in circulating tumor DNA level, change from baseline
Follow It assay, Canexia Health
Measured: Approximately three months
Histopathologic growth pattern as assessed by percent replacement, desmoplastic, and pushing features measured at the interface of liver metastasis and non tumoral liver
Measured: Three to four months
Post-operative minimal residual disease as assessed by circulating tumor DNA detection after tumor resection with curative intent
Follow It assay, Canexia Health
Measured: Approximately 1 months after resection with curative intent
Time to radiological recurrence after tumor resection with curative intent
Measured: 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
Measured: 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
Follow It assay, Canexia Health
Measured: Up to three years after tumor resection with curative intent
Secondary outcomes (5)
Incidence and grade of FOLFOX-induced neuropathy, as assessed by Sensory Subscale of the NCI CTCAE scale, version 3
Measured: 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
Measured: Two to three months pre-operatively and during post-operative adjuvant chemotherapy
Incidence of hospitalization for febrile neutropenia diagnosed by treating physicians
Measured: Two to three months pre-operatively and during post-operative adjuvant chemotherapy
Ninety-day post-surgical complications, defined by Clavien Dindo grading system
Measured: 90 days after tumor resection
Disease-specific survival after complete tumor resection
Measured: Up to three years after tumor resection with curative intent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Sep 2022
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Turcotte, MD, MSc, Principal investigator, CHUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068531
- Sponsor's protocol ID
- 21.103
- Acronym
- eDetect-mCRC
- Status last verified
- Apr 2024
- First submitted
- 2 Sep 2021
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05068531
- Acronym / sponsor ID
- eDetect-mCRC / 21.103
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- Real world data, Observational study, Circulating tumor DNA, Microbiome, Tumor immunology, Metastatic colorectal cancer, Liver metastasis, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In North America, colorectal cancer patients with resectable liver-restricted metastases (mCRC-LR) are treated with approximately 6 months of preoperative systemic multi-agent chemotherapy. Actuarial data however supports that approximately 20% of mCRC-LR patients can be cured without as much systemic chemotherapy. Prospective phase II-III trials also support that awaiting recurrence to initiate further metastases-targeted or systemic treatment may provide patients with longer overall survival while avoiding toxicities in those without recurrence.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding patients,
- Hereditary colorectal cancer (e.g., familial colonic polyposis or Lynch syndrome), and
- Presence of concurrent other cancer(s).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Turcotte, MD, MSc principal investigator
CHUM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wiam Belkaid, PhD (514-890-8000 ext. 23242, wiam.belkaid.chum@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological response to pre-operative chemotherapy as assessed by RECIST v1.1 (time frame: Approximately three months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.