CancerONCOBIOTICSNCT04567446
Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic Approach
An observational study of Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 9 sites in France.
Trial summary
Multicentric prospective study with collection of biological samples as part of type II research Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer
- What is being tested?
- Stool and Blood sample
- Type of treatment
- Injection or infusion
- How many people
- 1,100 participants
- Where
- 9 sitesFrance
- Study dates
- 22 Jan 2018to Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with cancer who will start treatment anticancer
Who may be able to join
- Patient with cancer who will start treatment anticancer (see cohorts).
- Patient information and signature of the consent form before any specific procedure for the study. The patient must be able and must be inclined to cooperate in the study procedures.
- Patient affiliated to a social security scheme or beneficiary of a similar scheme.
Who cannot join
- Pregnant or lactating woman
- Patient under guardianship or curatorship or deprived of liberty by a decision judicial or administrative or patient unable to give his consent.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Centre hospitalier du Pays d'Aix
Aix-en-Provence, 13616
Stéphanie MARTINEZ, MD, smartinez@ch-aix.fr
- Recruiting
Centre Pierre Curie
Beuvry, 62660
Jean-Briac PREVOST, MD, jean-briac.prevost@ichf.fr
- Recruiting
Clinique du Flandre
Coudekerque-Branche, 59210
Jean-Philippe WAGNER, MD, jpwagner@iadonco.org
- Recruiting
CHRU Lille - Hôpital Calmette
Lille, 59037
Arnaud SCHERPEREEL, MD, PhD, arnaud.SCHERPEREEL@chru-lille.fr
- Recruiting
Centre Léon Bérard
Lyon, 69008
Armelle VINCENEUX, MD, armelle.vinceneux@lyon.unicancer.fr
- Recruiting
Hôpital St Louis
Paris, 75010
Safae TERRISSE, MD, PhD, safae.terrisse@aphp.fr
- Recruiting
Hôpital Foch
Suresnes, 92151
Marie MAYENGA, MD, m.mayenga@hopital-foch.com
- Recruiting
Centre hospitalier TOULON - Sainte-Musse
Toulon, 83056
Clarisse AUDIGIER-VALETTE, MD, clarisse.audigier-valette@ch-toulon.fr
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94800
Cheick GUINDO, MD, PhD, +33 (0)1 42 11 54 66, Cheick.GUINDO@gustaveroussy.fr
About this study
Official title: Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic
Multicentric prospective study with collection of biological samples as part of type II research
- Conditions
- Cancer
- Being tested
- Stool, Blood sample
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StoolOther
collection at baseline (or before the third injection), at the first evaluation (CT-scan), at ≥ 6 months after the first injection, at toxicity and at relapse, at 1 week after the end of antibiotics treatment
Blood sampleOther
20 mL collection at baseline (or before the third injection), at the first evaluation (CT-scan), at ≥ 6 months after the first injection, at toxicity and at relapse, at 1 week after the end of antibiotics treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with bladder cancer who will start cancer treatment | Collection of biological samples (stool and blood) and data from patients included in the study will be performed:
1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy).
2. Collection of biological resources (all samples will be collected in fresh): stool and blood
3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant Receives: Other: Stool; Other: Blood sample | |
| Patients with Non-Small-Cell Lung cancer who will start cancer treatment | Collection of biological samples (stool and blood) and data from patients included in the study will be performed:
1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy).
2. Collection of biological resources (all samples will be collected in fresh): stool and blood
3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant Receives: Other: Stool; Other: Blood sample | |
| Patients with kidney cancer who will start cancer treatment | Collection of biological samples (stool and blood) and data from patients included in the study will be performed:
1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy).
2. Collection of biological resources (all samples will be collected in fresh): stool and blood
3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant Receives: Other: Stool; Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To define metagenomic signatures associated with cancer
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start22 Jan 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 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
- NCT04567446
- Sponsor's protocol ID
- 2017-A02010-53
- Other IDs
- 2017/2619
- Acronym
- ONCOBIOTICS
- Status last verified
- Jun 2024
- First submitted
- 10 Feb 2020
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovery of Microbiome-based Biomarkers for Patients With Cancer Using Metagenomic
- ClinicalTrials.gov ID
- NCT04567446
- Acronym / sponsor ID
- ONCOBIOTICS / 2017-A02010-53
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 22 Jan 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Sep 2020 (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.
Multicentric prospective study with collection of biological samples as part of type II research
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with bladder cancer who will start cancer treatment | – | Other: Stool, Other: Blood sampleCollection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant |
| Patients with Non-Small-Cell Lung cancer who will start cancer treatment | – | Other: Stool, Other: Blood sampleCollection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant |
| Patients with kidney cancer who will start cancer treatment | – | Other: Stool, Other: Blood sampleCollection of biological samples (stool and blood) and data from patients included in the study will be performed: 1. By identifying the patients who will start treatment anticancer (chemotherapy, hormone therapy, immunotherapy). 2. Collection of biological resources (all samples will be collected in fresh): stool and blood 3. Collection of clinical data corresponding to each patient included in the study by a clinical research assistant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with cancer who will start treatment anticancer
Key inclusion criteria (3 listed)
- Patient with cancer who will start treatment anticancer (see cohorts).
- Patient information and signature of the consent form before any specific procedure for the study. The patient must be able and must be inclined to cooperate in the study procedures.
- Patient affiliated to a social security scheme or beneficiary of a similar scheme.
Key exclusion criteria (2 listed)
- Pregnant or lactating woman
- Patient under guardianship or curatorship or deprived of liberty by a decision judicial or administrative or patient unable to give his consent.
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 |
|---|---|---|
| Stoolcollection at baseline (or before the third injection), at the first evaluation (CT-scan), at ≥ 6 months after the first injection, at toxicity and at relapse, at 1 week after the end of antibiotics treatment | Other | Patients with Non-Small-Cell Lung cancer who will start cancer treatment, Patients with bladder cancer who will start cancer treatment, Patients with kidney cancer who will start cancer treatment |
| Blood sample20 mL collection at baseline (or before the third injection), at the first evaluation (CT-scan), at ≥ 6 months after the first injection, at toxicity and at relapse, at 1 week after the end of antibiotics treatment | Other | Patients with Non-Small-Cell Lung cancer who will start cancer treatment, Patients with bladder cancer who will start cancer treatment, Patients with kidney cancer who will start cancer treatment |
Primary outcome
Overall survival
Time frame: Up to 2 years
To define metagenomic signatures associated with cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 9 sites 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 3 inclusion and 2 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 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Laurence Zitvogel, MD, PhD (+33 (0)1 42 11 42 11, laurence.zitvogel@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 2 years). 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 12 Jun 2024.