Metastatic Colorectal CancerNCT05299840
Impact of Using the Oncogramme® Device to Select the First Line of Treatment for Patients With Metastatic Colorectal Cancer
A study testing Oncogramme results available and Oncogramme results unavailable in people with Metastatic Colorectal Cancer, run by Oncomedics at 1 site in France.
Trial summary
Colorectal cancer is the 2nd leading cause of cancer death in France. Its incidence is nearly 45,000 new cases per year in 2017, with an estimated 5-year survival of 63% in 2015. Metastases are seen in 40-60% of colorectal cancer cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Oncogramme results available and Oncogramme results unavailable
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2023to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 18 years old and older
- Patient with suspected mCRC (synchronous or metachronous metastases (only if biopsy is required as part of routine care))
- Patient eligible for standard systemic chemotherapy (multidrug therapy such as FOLFOX, FOLFIRI, FOLFIRINOX, combined or not with anti- EGFR or anti-VEGF targeted therapies adapted to BRAF and RAS expression)
- colorectal adenocarcinoma histologically proven
- At least one measurable metastasis according to RECIST v1.1
- Chemotherapy for curative or palliative purposes
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- Oncograms® can be performed
- WHO score ≤ 2
- Life expectancy > 3 months
- neutrophils > 1500/mm3, platelets > 100 000/mm3, Hb > 9 g/dL
- Total bilirubin < 25 μmol/L, aspartate aminotransferase < 5 ULN (upper limits of normal), alanine aminotransferase < 5 ULN, alkaline phosphatase < 5 ULN, prothrombin rate > 60%, proteinuria < 1 g/24h
- No prior chemotherapy except peri-operative or adjuvant chemotherapy stopped more than 6 months ago
- Creatinine clearance > 50 mL/min according to MDRD formula
- Patient affiliated to a social security scheme
- Information to the patient and signature of the informed consent form.
Who cannot join
- Patients eligible for curative treatment (surgical and/or percutaneous) after discussion in multidisciplinary consultation meeting (isolated class I liver metastases)
- Patients with metachronous metastases not requiring biopsy as part of their standard management.
- Myocardial infarction, severe/unstable angina, coronary artery bypass grafting, New York Heart Association (NYHA) class II, III, or IV congestive heart failure, stroke, or transient ischemic attack within 6 months prior to inclusion
- HTA not controlled by medical treatment (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
- Active peptic ulcer
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- Deep wound or bone fracture not resolved within 3 months
- Major abdominal or extra-abdominal surgical procedure (except diagnostic biopsy or implantable site placement)
- Irradiation within 4 weeks prior to the start of treatment
- Transplant patients, HIV-positive, or other immunodeficiency syndromes
- Previous chemotherapy (except peri-operative or adjuvant chemotherapy discontinued more than 6 months ago)
- Any progressive disease not balanced during the last 6 months: hepatic insufficiency, renal insufficiency, respiratory insufficiency
- Peripheral neuropathy > 1 (CTCAE Common terminology criteria for adverse eventsv5.0)
- Patient with interstitial lung disease or pulmonary fibrosis
- History of chronic diarrhea or inflammatory disease of the colon or rectum, or occlusion or sub-occlusion unresolved with symptomatic treatment
- History of malignancy within the last 5 years except for properly treated non-metastatic colon cancer, basal cell skin carcinoma or carcinoma in situ of the uterine cervix
- Patient already included in another therapeutic trial with an investigational treatment or who has been out of a trial for less than 6 months
- Any specific contraindication or known allergy to the drugs used in the study.
- Known dihydropyrimidine dehydrogenase deficiency
- QT/QTc interval > 450 ms for men and > 470 ms for women
- Kalemia (K+) < LIN (lower limit to normal), magnesemia (Mg2+)< LIN, calcemia (Ca2+)< LIN
- Lack of effective contraception (at least 2 different means) in patients (male or/and female) of childbearing age, or for females, 12 months of confirmed amenorrhea, pregnant or lactating woman, woman of childbearing age who has not performed a pregnancy test (serum test)
- Persons deprived of liberty or under guardianship
- Impossible to undergo the medical follow-up of the trial for geographical, social or psychological reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Saint Joseph Marseille
Marseille, 13008
Cécile Bielmann, 0033 4 88 73 10 70, cbielmann@hopital-saint-joseph.fr
Christophe Laplace, claplace@hopital-saint-joseph.fr
About this study
Official title: Impact of Using the Oncogramme® Device to Select the First Line of Treatment (Chemotherapies +/- Targeted Therapies) for Patients With Metastatic Colorectal Cancer on Progression-free Survival, Treatment Costs, Efficiency and Quality of Life Compared to Usual Patient Care.
Colorectal cancer is the 2nd leading cause of cancer death in France. Its incidence is nearly 45,000 new cases per year in 2017, with an estimated 5-year survival of 63% in 2015. Metastases are seen in 40-60% of colorectal cancer cases. The 5-year survival rate ranges from 5% to 15% for patients with widespread metastatic disease.
Two types of treatments are used to treat colon cancer: surgery and medication protocol (chemotherapeutic drugs and targeted therapies). These treatments can be used alone or in combination.
Read more
The current choice of a first line of chemotherapy is left to the practitioner's discretion, after consultation with a multidisciplinary consultation meeting. The choice of treatment(s) depends on official recommendations and is based on the results of clinical trials conducted on large populations, and takes into account the toxicities of the therapies used and the general condition of the patients. The therapeutic combinations for colorectal cancers are therefore multiple. However, to date, no consensus has been reached to ensure that each patient is treated effectively and as a unique case.
Today, functional sensitivity tests offer the possibility for patients to be offered a personalized treatment against cancer. This is the case of the Oncogramme® device developed by Oncomedics, which is the first functional sensitivity test dedicated to oncology in Europe. It is based on an in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available (chemotherapy ± targeted therapy). This response, translated into a tumor-specific sensitivity profile, can be used by the medical team to determine the most appropriate treatment for the patient. This test is therefore likely to improve the benefit-risk ratio of a chemotherapy treatment in colorectal cancer by allowing the medical team to select, among the treatments deemed effective, the one that will be the most effective on the tumor and possibly with the least side effects.
The hypothesis of this study is that the personalization of treatments (by chemotherapy associated or not with targeted therapies) proposed by the Oncogramme®-colorectal device would allow to promote the best possible clinical response, to limit the side effects and ultimately to improve the survival and the quality of life of the patient.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Oncogramme results available, Oncogramme results unavailable
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncogramme results availableDiagnostic test
in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available
Oncogramme results unavailableDiagnostic test
in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available
| Study group | Role | What they receive |
|---|---|---|
| Oncogramme group | Experimental | The oncologist has access to the results of the Oncogramme® Device and decides on the treatment according to the recommendations of the Oncogramme® Device Receives: Diagnostic Test: Oncogramme results available |
| Control group | Other | The oncologist does not have access to the results of the Oncogramme® Device and decides on the treatment according to the standard of care. Receives: Diagnostic Test: Oncogramme results unavailable |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 12 months
progression-free survival
Measured: 24 months
Secondary outcomes (9)
Objective response rates
Sum of complete and partial remission rates measured according to RECIST v1.1
Measured: 12 months
Objective response rates
Sum of complete and partial remission rates measured according to RECIST v1.1
Measured: 24 months
Response time
Time from first recognition of response to first recognition of progress
Measured: 12 months
Rate of treatment change due to tumor progression
Measured: 2 months
Overall survival
Measured: 24 months
Diagnostic performance of the Oncogramme device
Calculation of the sensitivity, specificity, and predictive Values of the Oncogramme device
Measured: 12 months
Budget impact
Calculation of incremental and avoided costs per patient
Measured: 12 months
Quality of life of patients
measured using EORTC core quality of life questionnaire (QLQ-C30)
Measured: 12 months
Quality of life of patients
measured using EORTC core quality of life questionnaire (QLQ-C30)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start7 Jun 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncomedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital St. Joseph, Marseille, France
- Responsible party
- Sponsor
- Investigators
- Hervé Perrier, M.D, Principal investigator, Hopital Saint Joseph Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299840
- Sponsor's protocol ID
- ONCOG
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2022
- Last updated
- 27 Mar 2025
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using the Oncogramme® Device to Select the First Line of Treatment (Chemotherapies +/- Targeted Therapies) for Patients With Metastatic Colorectal Cancer on Progression-free Survival, Treatment Costs, Efficiency and Quality of Life Compared to Usual Patient Care.
- ClinicalTrials.gov ID
- NCT05299840
- Acronym / sponsor ID
- ONCOG
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- OncomedicsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital St. Joseph, Marseille, France
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 29 Mar 2022 (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.
Colorectal cancer is the 2nd leading cause of cancer death in France. Its incidence is nearly 45,000 new cases per year in 2017, with an estimated 5-year survival of 63% in 2015. Metastases are seen in 40-60% of colorectal cancer cases. The 5-year survival rate ranges from 5% to 15% for patients with widespread metastatic disease.
Two types of treatments are used to treat colon cancer: surgery and medication protocol (chemotherapeutic drugs and targeted therapies). These treatments can be used alone or in combination.
The current choice of a first line of chemotherapy is left to the practitioner's discretion, after consultation with a multidisciplinary consultation meeting. The choice of treatment(s) depends on official recommendations and is based on the results of clinical trials conducted on large populations, and takes into account the toxicities of the therapies used and the general condition of the patients. The therapeutic combinations for colorectal cancers are therefore multiple. However, to date, no consensus has been reached to ensure that each patient is treated effectively and as a unique case.
Today, functional sensitivity tests offer the possibility for patients to be offered a personalized treatment against cancer. This is the case of the Oncogramme® device developed by Oncomedics, which is the first functional sensitivity test dedicated to oncology in Europe. It is based on an in vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available (chemotherapy ± targeted therapy). This response, translated into a tumor-specific sensitivity profile, can be used by the medical team to determine the most appropriate treatment for the patient. This test is therefore likely to improve the benefit-risk ratio of a chemotherapy treatment in colorectal cancer by allowing the medical team to select, among the treatments deemed effective, the one that will be the most effective on the tumor and possibly with the least side effects.
The hypothesis of this study is that the personalization of treatments (by chemotherapy associated or not with targeted therapies) proposed by the Oncogramme®-colorectal device would allow to promote the best possible clinical response, to limit the side effects and ultimately to improve the survival and the quality of life of the patient.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncogramme group | Experimental | Diagnostic Test: Oncogramme results availableThe oncologist has access to the results of the Oncogramme® Device and decides on the treatment according to the recommendations of the Oncogramme® Device |
| Control group | Other | Diagnostic Test: Oncogramme results unavailableThe oncologist does not have access to the results of the Oncogramme® Device and decides on the treatment according to the standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18 years old and older
- Patient with suspected mCRC (synchronous or metachronous metastases (only if biopsy is required as part of routine care))
- Patient eligible for standard systemic chemotherapy (multidrug therapy such as FOLFOX, FOLFIRI, FOLFIRINOX, combined or not with anti- EGFR or anti-VEGF targeted therapies adapted to BRAF and RAS expression)
- colorectal adenocarcinoma histologically proven
- At least one measurable metastasis according to RECIST v1.1
Key exclusion criteria (24 listed)
- Patients eligible for curative treatment (surgical and/or percutaneous) after discussion in multidisciplinary consultation meeting (isolated class I liver metastases)
- Patients with metachronous metastases not requiring biopsy as part of their standard management.
- Myocardial infarction, severe/unstable angina, coronary artery bypass grafting, New York Heart Association (NYHA) class II, III, or IV congestive heart failure, stroke, or transient ischemic attack within 6 months prior to inclusion
- HTA not controlled by medical treatment (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
- History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
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 |
|---|---|---|
| Oncogramme results availablein vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available | Diagnostic test | Oncogramme group |
| Oncogramme results unavailablein vitro analysis of each patient's tumor cells in order to compare the responses of the tumor cells to the different molecules and therapeutic combinations available | Diagnostic test | Control group |
Primary outcome
progression-free survival
Time frame: 12 months
progression-free survival
Time frame: 24 months
9 secondary outcomes
Objective response rates
Time frame: 12 months
Objective response rates
Time frame: 24 months
Response time
Time frame: 12 months
Rate of treatment change due to tumor progression
Time frame: 2 months
Overall survival
Time frame: 24 months
Diagnostic performance of the Oncogramme device
Time frame: 12 months
Budget impact
Time frame: 12 months
Quality of life of patients
Time frame: 12 months
Quality of life of patients
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- 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.
Hervé Perrier, M.D principal investigator
Hopital Saint Joseph Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncogramme results available and Oncogramme results unavailable in people with Metastatic Colorectal Cancer, run by Oncomedics 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 15 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Lautrette, PhD (0033 5 55 33 85 25, c.lautrette@oncomedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 12 months). The study lists 2 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 27 Mar 2025.