OncologyCatalogue-OncoNCT03196609
Characteristics of the Intestinal Microbiota in Patients With Cancer
A study testing Collection of stool and serum samples in people with Oncology, run by Centre Georges Francois Leclerc at 2 sites in France.
Trial summary
In order to understand how the intestinal microbiota plays a role in the effectiveness of an anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a catalog of microbial genes of a patient with cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oncology
- What is being tested?
- Collection of stool and serum samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Feb 2017to 5 Jul 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women between 18 and 75 years of age.
- Patients with one of the following types of cancer: non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, breast cancer, prostate cancer and glioblastoma
- Patients with informed consent to participate in the study.
- Affiliation to the social security system
Who cannot join
- For patients with hepatocellular cancer, patients infected with the human immunodeficiency virus (HIV)
- Patients who are unable to understand, read and / or sign informed consent
- Patients who can not collect / send stools for geographical, social or psychological reasons
- Patients with previous cancer in the 5 years preceding this study
- Persons benefiting from a system of protection for adults (including guardianship and curatorship)
- Pregnant or nursing women
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- Patients with another synchronous tumor
- Patients with fecal transplant
- Patients with chronic inflammatory bowel disease (IBD)
- Patients having had in the 3 months preceding the collection of stool: colonoscopy, bariatric surgery, surgical removal of a segment of the small intestine (enteritomy or enterostomy), parenteral nutrition.
- Patients who had had antibiotic therapy within 1 month before stool collection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Georges-François Leclerc
Dijon, 21079
Hopital Universitaire Paul Brousse
Villejuif, 94800
About this study
Official title: Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)
In order to understand how the intestinal microbiota plays a role in the effectiveness of an anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a catalog of microbial genes of a patient with cancer. This catalog will help to characterize the intestinal microbiota of cancer patients and to be able to use this catalog as a reference tool for screening the microbiota of patients treated with immune control point inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.
The metagenomic analysis of a group of five different types of cancers introduces a lot of heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer treated with immune control point inhibitors, two stool collections will be performed per patient (one stool collection before setting up an immune control point inhibitor and one collection after one month of being inhibited Of immune control point) to assess the impact of the immune control point inhibitor on the microbiota (pilot study). For this study, two stool collection tubes containing different preservative solutions will be used (one RNAlater tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).
In parallel, we will also collect samples of serum and plasma to evaluate, in a second step, protein markers in circulating blood.
Read the detailed description
Primary objective: Develop a catalog of microbial genes dedicated to oncology (Onco catalog) by sequencing stool specimens from patients with cancer.
- Conditions
- Oncology
- Being tested
- Collection of stool and serum samples
- Keywords
- Intestinal microbiota, microbial genes, oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of stool and serum samplesBiological
During the inclusion visit (for the 5 cancer sites): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) +Blood sample (1 tube SST + 1 tube EDTA)
1 month after treatment (only for non-small cell lung cancer): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) + Blood sample (1 tube SST + 1 tube EDTA)
| Study group | Role | What they receive |
|---|---|---|
| Cohorte | Experimental | This cohort will consist of patients as described below:
* 15 patients with non-small cell lung cancer (NSCLC)
* 10 patients with hepatocellular cancer:
* 10 patients with colorectal cancer
* 10 patients with breast cancer
* 10 patients with prostate cancer
* 10 patients with glioblastoma Receives: Biological: Collection of stool and serum samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial DNA
Bio-computer and bio-statistical analyzes will be carried out in order to constitute the gene catalog.
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start6 Feb 2017
- Primary completion6 Feb 2017
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This cohort will consist of 55 patients as described below: * non-small cell lung cancer (NSCLC) * hepatocellular cancer: * colorectal cancer * breast cancer * prostate cancer * glioblastoma
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Collaborators
- Enterome
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196609
- Sponsor's protocol ID
- Catalogue-Onco
- Acronym
- Catalogue-Onco
- Status last verified
- Jan 2020
- First submitted
- 21 Jun 2017
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of the Intestinal Microbiota in Patients With Cancer (Catalogue-Onco)
- ClinicalTrials.gov ID
- NCT03196609
- Acronym / sponsor ID
- Catalogue-Onco / Catalogue-Onco
- Conditions
- Oncology
- Keywords
- Intestinal microbiota, microbial genes, oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Collaborators
- Enterome
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 6 Feb 2017 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 23 Jun 2017 (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 order to understand how the intestinal microbiota plays a role in the effectiveness of an anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a catalog of microbial genes of a patient with cancer. This catalog will help to characterize the intestinal microbiota of cancer patients and to be able to use this catalog as a reference tool for screening the microbiota of patients treated with immune control point inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.
The metagenomic analysis of a group of five different types of cancers introduces a lot of heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer treated with immune control point inhibitors, two stool collections will be performed per patient (one stool collection before setting up an immune control point inhibitor and one collection after one month of being inhibited Of immune control point) to assess the impact of the immune control point inhibitor on the microbiota (pilot study). For this study, two stool collection tubes containing different preservative solutions will be used (one RNAlater tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).
In parallel, we will also collect samples of serum and plasma to evaluate, in a second step, protein markers in circulating blood.
Detailed description
Primary objective: Develop a catalog of microbial genes dedicated to oncology (Onco catalog) by sequencing stool specimens from patients with cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This cohort will consist of 55 patients as described below: * non-small cell lung cancer (NSCLC) * hepatocellular cancer: * colorectal cancer * breast cancer * prostate cancer * glioblastoma
| Arm | Type | Receives |
|---|---|---|
| Cohorte | Experimental | Biological: Collection of stool and serum samplesThis cohort will consist of patients as described below: * 15 patients with non-small cell lung cancer (NSCLC) * 10 patients with hepatocellular cancer: * 10 patients with colorectal cancer * 10 patients with breast cancer * 10 patients with prostate cancer * 10 patients with glioblastoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women between 18 and 75 years of age.
- Patients with one of the following types of cancer: non-small cell lung cancer, hepatocellular carcinoma, colorectal cancer, breast cancer, prostate cancer and glioblastoma
- Patients with informed consent to participate in the study.
- Affiliation to the social security system
Key exclusion criteria (11 listed)
- For patients with hepatocellular cancer, patients infected with the human immunodeficiency virus (HIV)
- Patients who are unable to understand, read and / or sign informed consent
- Patients who can not collect / send stools for geographical, social or psychological reasons
- Patients with previous cancer in the 5 years preceding this study
- Persons benefiting from a system of protection for adults (including guardianship and curatorship)
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 |
|---|---|---|
| Collection of stool and serum samplesDuring the inclusion visit (for the 5 cancer sites): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) +Blood sample (1 tube SST + 1 tube EDTA) 1 month after treatment (only for non-small cell lung cancer): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) + Blood sample (1 tube SST + 1 tube EDTA) | Biological | Cohorte |
Primary outcome
Microbial DNA
Time frame: inclusion
Bio-computer and bio-statistical analyzes will be carried out in order to constitute the gene catalog.
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 27 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of stool and serum samples in people with Oncology, run by Centre Georges Francois Leclerc at 2 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 4 inclusion and 11 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Microbial DNA (time frame: inclusion). 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 Jan 2020.