Carcinoma of the OvarymiRSaNCT01391351
Search for Predictors of Therapeutic Response in Ovarian Carcinoma
A study testing blood samples in people with Carcinoma of the Ovary and Fallopian Tube Cancer, run by Centre Francois Baclesse at 7 sites in France.
Trial summary
In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Carcinoma of the Ovary, Fallopian Tube Cancer, Peritoneal Serous-type Advanced Stage
- What is being tested?
- blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 7 sitesFrance
- Study dates
- Jun 2011to Jul 2016
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cancer of the ovary, peritoneum or of the fallopian tube
- Stage III or IV
- Cancer of serous histology
- Patients of any chemotherapy naive
- Patients should receive treatment with chemotherapy for first line by Taxol- Carboplatin. Avastin is authorized in concomitant.
- An initial surgery or through authorized
- Patients who signed informed consent
- Patients over the age of 18 years
Who cannot join
- Patients being treated for another cancer chemotherapy and / or hormone therapy
- Patients receiving other chemotherapy Taxol-carboplatin associated or not to avastin
- Patients under guardianship
- Previous history of pelvic radiotherapy
- History of malignancy blood
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Institut de cancerologie de la loire
Angers, 49000
Centre François BACLESSE
Caen, Calvados, 14076
Centre Oscar LAMBRET
Lille, Nord, 59000
Centre Réné Gauducheau
Nantes, Loire-Atlantique, 44 000
Institut CURIE
Paris, 75000
Centre Eugène Marquis
Rennes, Brittany Region, 35 000
Centre Henri Becquerel
Rouen, Seine Maritime, 76 000
About this study
Official title: Search for Predictors of Therapeutic Response in Patients With Carcinoma of the Ovary, the Fallopian Tube or Peritoneal Serous-type Advanced
In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).
- Being tested
- blood samples
- Keywords
- carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, chemotherapy with Taxol and Carboplatin, predictors of therapeutic response, serum miRNA, identification of polymorphisms or SNPs (Single Nucleotide Polymorphism)
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesOther
blood samples in patients receiving Taxol and carboplatin chemotherapy :
- On Day 1 of the first course of chemotherapy
- On Day 1 of the second course of chemotherapy
- Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy
- At the end of chemotherapy
blood samplesOther
blood samples in patients receiving Taxol and carboplatin chemotherapy with avastin:
- On Day 1 of the first course of chemotherapy
- On Day 1 of the second course of chemotherapy
- Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy
- At the end of chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Taxol and carboplatin | Other | blood samples in patients receiving Taxol and carboplatin chemotherapy Receives: Other: blood samples |
| Taxol, carboplatin and avastin | Other | blood samples in patients receiving Taxol, carboplatin chemotherapy with avastin Receives: Other: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
search for predictors of response to chemotherapy
the search for predictors of response to chemotherapy in patients with carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced by using (i) the miRNA profile of serum before treatment with chemotherapy and (ii) the identification of polymorphisms or SNPs (Single Nucleotide polymorphism) in particular genes involved in the metabolism of chemotherapy agents
Measured: 12 months after beginning treatment
Secondary outcomes (2)
profiling miRNA expression
- Characterization of the response to treatment with profiling miRNA expression after the first course of chemotherapy in patients with carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced
Measured: 1 month
study of changes in serum miRNA expression
- The study of changes in serum miRNA expression identified as predictive of tumor response during chemotherapy treatment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of the OvaryStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence JOLY-LOBBEDEZ, PD, Principal investigator, Centre François BaclesseSophie KRIEGER, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391351
- Sponsor's protocol ID
- miRSa
- Acronym
- miRSa
- Status last verified
- Jul 2016
- First submitted
- 8 Jul 2011
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Search for Predictors of Therapeutic Response in Patients With Carcinoma of the Ovary, the Fallopian Tube or Peritoneal Serous-type Advanced
- ClinicalTrials.gov ID
- NCT01391351
- Acronym / sponsor ID
- miRSa / miRSa
- Keywords
- carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, chemotherapy with Taxol and Carboplatin, predictors of therapeutic response, serum miRNA, identification of polymorphisms or SNPs (Single Nucleotide Polymorphism)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 Jul 2011 (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.
In order to search for predictors of response to chemotherapy in patients with ovarian carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced stage, we will define the comparative profiles of miRNA expression of serum polymorphisms and determine differential in 2 patient populations (with or without recurrence 6 months after completion of chemotherapy) with (i) the miRNA profile of serum before treatment and (ii) identification of polymorphisms or SNP (Single Nucleotide Polymorphism) in particular genes involved in the metabolism of chemotherapy agents In the case of miRNA, expression profiles will also be studied during the first course in response to chemotherapy. Indeed, the miRNA profile of serum may be different at baseline among the 2 types of populations (or non-recurrence at 6 months).
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Taxol and carboplatin | Other | Other: blood samplesblood samples in patients receiving Taxol and carboplatin chemotherapy |
| Taxol, carboplatin and avastin | Other | Other: blood samplesblood samples in patients receiving Taxol, carboplatin chemotherapy with avastin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with cancer of the ovary, peritoneum or of the fallopian tube
- Stage III or IV
- Cancer of serous histology
- Patients of any chemotherapy naive
- Patients should receive treatment with chemotherapy for first line by Taxol- Carboplatin. Avastin is authorized in concomitant.
Key exclusion criteria (5 listed)
- Patients being treated for another cancer chemotherapy and / or hormone therapy
- Patients receiving other chemotherapy Taxol-carboplatin associated or not to avastin
- Patients under guardianship
- Previous history of pelvic radiotherapy
- History of malignancy blood
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 |
|---|---|---|
| blood samplesblood samples in patients receiving Taxol and carboplatin chemotherapy : * On Day 1 of the first course of chemotherapy * On Day 1 of the second course of chemotherapy * Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy * At the end of chemotherapy | Other | Taxol and carboplatin |
| blood samplesblood samples in patients receiving Taxol and carboplatin chemotherapy with avastin: * On Day 1 of the first course of chemotherapy * On Day 1 of the second course of chemotherapy * Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy * At the end of chemotherapy | Other | Taxol, carboplatin and avastin |
Primary outcome
search for predictors of response to chemotherapy
Time frame: 12 months after beginning treatment
the search for predictors of response to chemotherapy in patients with carcinoma of the ovary, the fallopian tube or peritoneal serous-type advanced by using (i) the miRNA profile of serum before treatment with chemotherapy and (ii) the identification of polymorphisms or SNPs (Single Nucleotide polymorphism) in particular genes involved in the metabolism of chemotherapy agents
2 secondary outcomes
profiling miRNA expression
Time frame: 1 month
study of changes in serum miRNA expression
Time frame: 6 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 21 Jul 2016.
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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.
Florence JOLY-LOBBEDEZ, PD principal investigator
Centre François Baclesse
Sophie KRIEGER, MD principal investigator
Centre François Baclesse
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples in people with Carcinoma of the Ovary and Fallopian Tube Cancer, run by Centre Francois Baclesse at 7 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 8 inclusion and 5 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 21 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
search for predictors of response to chemotherapy (time frame: 12 months after beginning treatment). 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 21 Jul 2016.