Colorectal Cancer MetastaticPRECISION-FNCT01932489
The Jules Bordet Institute Molecular Profiling Program Feasibility Trial
A study testing Biopsy of a metastatic lesion. in people with Colorectal Cancer Metastatic and Metastatic Melanoma, run by Jules Bordet Institute at 1 site in Belgium.
Trial summary
Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Metastatic Melanoma, Metastatic Non-Small Cell Lung Carcinoma
- What is being tested?
- Biopsy of a metastatic lesion.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2013to Oct 2014
- 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
- Written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study.
- Age ≥ 18 years.
- Histologically proven metastatic or locally recurrent CRC, NSCLC or melanoma.
- Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for research purposes.
Who cannot join
- Eastern Cooperative Oncology Group (ECOG) Performance Status >2.
- The biopsy procedure is estimated to be too risky for the patient.
- Any anti-VEGF or anti-VEGFR treatment administered less than 3 weeks before new biopsy procedure.
- No appropriate washout period for patients on anticoagulation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.
Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays.
Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen assay will be performed using DNA sequencing.
Results will be discussed during a molecular screening tumor board.
- Conditions
- Colorectal Cancer Metastatic, Metastatic Melanoma, Metastatic Non-Small Cell Lung Carcinoma
- Being tested
- Biopsy of a metastatic lesion.
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy of a metastatic lesion.Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sequencing of a metastatic lesion. | Other | Biopsy of a metastatic lesion followed by a targeted cancer gene screen. Receives: Procedure: Biopsy of a metastatic lesion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of the biopsies
Percentage of frozen and FFPE core biopsies that are able to provide at least 1.5 μg of DNA of high quality suitable for molecular testing.
Measured: 1 month
Technical failure rate.
Frequency of failures of each pathological and molecular tests.
Measured: 1 month
Percentage of patients with results within the specified turnaround time
Percentage of patients for whom biopsy was performed within 10 working days from signature of the ICF and for whom all central laboratory results (pathology and molecular) will be available to the investigator within 15 working days from the time samples are received at the central laboratory (JBI).
Measured: 1 month
Secondary outcomes (1)
Feasibility of a tumor sequencing board.
Ability of the "tumor sequencing board" to assign patients to ongoing clinical trials.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionOct 2014
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.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Aftimos, MD, Principal investigator, Jules Bordet Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932489
- Sponsor's protocol ID
- IJBCE2139
- Acronym
- PRECISION-F
- Status last verified
- Oct 2014
- First submitted
- 23 Aug 2013
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE JULES BORDET INSTITUTE PROGRAM FOR MOLECULAR PROFILING OF METASTATIC LESIONS: FEASIBILITY. PRECISION - Feasibility.
- ClinicalTrials.gov ID
- NCT01932489
- Acronym / sponsor ID
- PRECISION-F / IJBCE2139
- Conditions
- Colorectal Cancer Metastatic, Metastatic Melanoma, Metastatic Non-Small Cell Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Aug 2013 (estimated)
- 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.
Prior to the use of genomic tests for patient inclusion in clinical trials, it is essential for the Jules Bordet Institute (JBI) to pilot the logistical and technical aspects by examining the feasibility and turnaround time of performing and obtaining data from a few key molecular assays.
Patients with metastatic colorectal cancer, non-small cell lung cancer or melanoma will be enrolled. Biopsie from metastatic lesions will be performed. A targeted cancer gene screen assay will be performed using DNA sequencing.
Results will be discussed during a molecular screening tumor board.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequencing of a metastatic lesion. | Other | Procedure: Biopsy of a metastatic lesion.Biopsy of a metastatic lesion followed by a targeted cancer gene screen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent for all study procedures according to local regulatory requirements prior to enrollment into the study.
- Age ≥ 18 years.
- Histologically proven metastatic or locally recurrent CRC, NSCLC or melanoma.
- Tumor tissue (FFPE and frozen) from recurrent or metastatic lesions available for research purposes.
Key exclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) Performance Status >2.
- The biopsy procedure is estimated to be too risky for the patient.
- Any anti-VEGF or anti-VEGFR treatment administered less than 3 weeks before new biopsy procedure.
- No appropriate washout period for patients on anticoagulation therapy.
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 |
|---|---|---|
| Biopsy of a metastatic lesion. | Procedure or surgery | Sequencing of a metastatic lesion. |
Primary outcome
Quality of the biopsies
Time frame: 1 month
Percentage of frozen and FFPE core biopsies that are able to provide at least 1.5 μg of DNA of high quality suitable for molecular testing.
Technical failure rate.
Time frame: 1 month
Frequency of failures of each pathological and molecular tests.
Percentage of patients with results within the specified turnaround time
Time frame: 1 month
Percentage of patients for whom biopsy was performed within 10 working days from signature of the ICF and for whom all central laboratory results (pathology and molecular) will be available to the investigator within 15 working days from the time samples are received at the central laboratory (JBI).
1 secondary outcome
Feasibility of a tumor sequencing board.
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
Related trials for Colorectal Cancer Metastatic
RecruitingEarly Phase 1
Neuroprotective Potential of Cannabidiol (CBD) in Preventing Oxaliplatin (Ox)-Induced Neuropathy
Oxaliplatin Induced Peripheral Neuropathy in Cancer Patients, Metastatic Colorectal Cancer (CRC)
Not yet recruitingObservational study
SGA-OCRC: Prediction of 90-Day Major Adverse Postoperative Outcomes in Octogenarians With Resectable Colorectal Cancer
Octogenarian Patients With Non-metastatic Resectable Colorectal Cancer
RecruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
Metastatic Colorectal Carcinoma, Metastatic Malignant Solid Neoplasm
RecruitingPhase 1
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Solid Tumor, Adult, Metastatic Solid Tumor
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
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.
Philippe Aftimos, MD principal investigator
Jules Bordet Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy of a metastatic lesion. in people with Colorectal Cancer Metastatic and Metastatic Melanoma, run by Jules Bordet Institute at 1 site in Belgium.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 May 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of the biopsies (time frame: 1 month). The study lists 3 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 23 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.