Colorectal CancerDISCOVERNCT03613194
Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer
A study testing Sampling in people with Colorectal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jun 2018to Jun 2020
- Phase
- Interventional
- 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
Who may be able to join
- Age > 18 years
- Histological Diagnosis of stage IV colorectal cancer
- Hepatic metastasis and/or peritoneal potentially resecable
- Patient affiliated with a mode of the social security or recipient of such a mode
- Information of the patient or his legal representative and collection of his assent
Who cannot join
- None metastatic colorectal cancer
- Cancer of appendicular origin
- Patients deprived of liberty or unable to give his assent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94805
Diane GOERE, MD, 0142114211 ext. +33, diane.goere@gustaveroussy.fr
About this study
To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers
- Conditions
- Colorectal Cancer
- Being tested
- Sampling
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingProcedure or surgery
After inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples.
The samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern:
- Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal
- Peritoneal liquid
- none tumoral peritoneum
- Portal blood
- Peripheral blood
- Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum.
In the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic colorectal cancer | Other | After inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples.
The samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern:
* Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal
* Peritoneal liquid
* none tumoral peritoneum
* Portal blood
* Peripheral blood
* Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum.
In the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator. Receives: Procedure: Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and characterization of the tumoral intermediaries on the overflowing peritoneal
After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.
Measured: Up to 24 months
Identification and characterization of the tumoral intermediaries on the portal blood
After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.
Measured: Up to 24 months
Identification and characterization of the tumoral intermediaries on the peripheral blood
After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.
Measured: Up to 24 months
Identification and characterization of the tumoral intermediaries on the hepatic metastasis and/or peritoneal)
After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start25 Jun 2018
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613194
- Sponsor's protocol ID
- 2017-A02878-45
- Other IDs
- 2017/2511
- Acronym
- DISCOVER
- Status last verified
- Jul 2018
- First submitted
- 19 Jul 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic and Molecular Study of the Process of Metastatic Dissemination in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03613194
- Acronym / sponsor ID
- DISCOVER / 2017-A02878-45
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 3 Aug 2018 (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.
To confirm the role of the collective dissemination in the mechanisms of tumoral invasion of colorectal cancers
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic colorectal cancer | Other | Procedure: SamplingAfter inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples. The samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern: * Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal * Peritoneal liquid * none tumoral peritoneum * Portal blood * Peripheral blood * Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum. In the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Histological Diagnosis of stage IV colorectal cancer
- Hepatic metastasis and/or peritoneal potentially resecable
- Patient affiliated with a mode of the social security or recipient of such a mode
- Information of the patient or his legal representative and collection of his assent
Key exclusion criteria (3 listed)
- None metastatic colorectal cancer
- Cancer of appendicular origin
- Patients deprived of liberty or unable to give his assent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamplingAfter inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples. The samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern: * Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal * Peritoneal liquid * none tumoral peritoneum * Portal blood * Peripheral blood * Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum. In the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator. | Procedure or surgery | Patients with metastatic colorectal cancer |
Primary outcome
Identification and characterization of the tumoral intermediaries on the overflowing peritoneal
Time frame: Up to 24 months
After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.
Identification and characterization of the tumoral intermediaries on the portal blood
Time frame: Up to 24 months
After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.
Identification and characterization of the tumoral intermediaries on the peripheral blood
Time frame: Up to 24 months
After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.
Identification and characterization of the tumoral intermediaries on the hepatic metastasis and/or peritoneal)
Time frame: Up to 24 months
After several separation and centrifugation steps, clusters and tumor cells are isolated and counted in the various biological samples. The different isolated intermediates will be analyzed by immunolabeling with the antibodies directed against CK20, EpCAM, Vimentine and CD45.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling in people with Colorectal Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 5 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 3 Aug 2018. 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 France. 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 Diane GOERE, MD (0142114211 ext. +33, diane.goere@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and characterization of the tumoral intermediaries on the overflowing peritoneal (time frame: Up to 24 months). The study lists 4 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 3 Aug 2018.