Breast CancerCASOHARNCT02560818
Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer
A study testing collection of a blood sample and breast and ovarian tissue and use of a previous blood collection for patients in people with Breast Cancer and Transcriptomes, run by Centre Francois Baclesse at 1 site in France.
Trial summary
This is a case-control study of molecular diagnostics. This study requires two steps: The first part of the study will be conducted on a population of 20 women without breast cancer and, or ovarian family (Healthy Volunteers controls) The second part of the study will be conducted on a population of 50 patients… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Transcriptomes, Molecular Diagnostic
- What is being tested?
- collection of a blood sample and breast and ovarian tissue and use of a previous blood collection for patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2020
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For population A
- Women without a history of breast cancer and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before age 60 for ovarian cancer
- Age 18-65 years
- Women targeted for breast reduction surgery
- Agreeing to participate in the study (collection of signed informed consent)
- For population B
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- Women over the age of 18, with no previous history of breast and / or ovarian cancer and no family history of breast and / or early ovarian cancer in first and second degree relatives, ( diagnosis before age 50 for breast cancer and before age 60 for ovarian cancer).
- Women to be operated on for a hysterectomy with annexectomy or an annexectomy in a benign indication
- For population C :
- Women with a history of breast cancer between 50 and 65 years of age but no history of ovarian cancer and no family history of breast and / or ovarian cancer in first- and second-degree relatives before 50 years of age breast cancer and before age 60 for ovarian cancer
- Women who have been treated for breast cancer and undergoing contralateral symmetrization surgery
Who cannot join
- Men
- Personal history (for population A and B) or family history (populations A, B, C) of breast and / or ovarian cancer (known breast or ovarian cancer in their family of 1st and 2nd degree before age 50 for breast cancer and before age 60 for ovarian cancer)
- Population C: breast cancer under 50 years
- Persons deprived of liberty or guardianship (including curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
This is a case-control study of molecular diagnostics.
This study requires two steps:
- The first part of the study will be conducted on a population of 20 women without breast cancer and, or ovarian family (Healthy Volunteers controls)
- The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls .
For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL study, ID-RCB 2009-A00833-54) will be used.
Read the detailed description
This study requires two steps:
- The first part of the study will be conducted on a population of 20 women free of breast cancer and, or ovarian Family (healthy volunteers controls) and without a known family history of breast and or ovarian cancer.
Mapping the level of blood (leukocytes) and the breast tissue will be drawn for the same individual on the physiological profiles splicing of the messenger RNA of genes involved in this predisposition, targeted by high-throughput sequencing of RNA (RNASeq).
A direct comparison of RNA splicing patterns between blood and breast tissue from the same witness will detect any differences between these two tissues.
-The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls with no known family history of breast and, or ovarian cancer.
Analysis of the results will highlight potential splicing abnormalities.
- Conditions
- Breast Cancer, Transcriptomes, Molecular Diagnostic, Ovarian Cancer
- Being tested
- collection of a blood sample and breast and ovarian tissue, use of a previous blood collection for patients
- Keywords
- splice profiles of messenger RNA
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of a blood sample and breast and ovarian tissueOther
a blood sample and a breast and ovarian tissue sample will be collected in healthy women during their surgery (breast or ovarian surgery according to selection group :A, B or C)
use of a previous blood collection for patientsOther
| Study group | Role | What they receive |
|---|---|---|
| Control population : Healthy Volunteers | Active comparator | 20 Healthy Volunteers will be recruited:
* 10 women to recover breast tissue (from surgical waste) : populations A and C
* 10 women to recover ovarian tissue (from surgical waste) : population B Receives: Other: collection of a blood sample and breast and ovarian tissue |
| Patients | Experimental | blood samples of 50 patients will be used (use of blood collection in study EXSAL N°ID-RCB 2009-A00833-54) Receives: Other: use of a previous blood collection for patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the average rate of inclusion of exons (exon inclusion mean level) messenger RNA leucocyte of patients and the controls (without matching)
Measured: at inclusion
Secondary outcomes (1)
Difference between the average rate of inclusion of exons (exon inclusion mean level) leukocyte messenger RNAs and, the mRNA of breast tissue in healthy women (with pairing).
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie KRIEGER, MD, Principal investigator, Centre François Baclesse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560818
- Sponsor's protocol ID
- CASOHAR
- Acronym
- CASOHAR
- Status last verified
- Nov 2020
- First submitted
- 24 Sep 2015
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer
- ClinicalTrials.gov ID
- NCT02560818
- Acronym / sponsor ID
- CASOHAR / CASOHAR
- Conditions
- Breast Cancer, Transcriptomes, Molecular Diagnostic, Ovarian Cancer
- Keywords
- splice profiles of messenger RNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 25 Sep 2015 (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.
This is a case-control study of molecular diagnostics.
This study requires two steps:
- The first part of the study will be conducted on a population of 20 women without breast cancer and, or ovarian family (Healthy Volunteers controls)
- The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls .
For analysis of leucocytes of the patients, a blood sample collected in a prior study (EXSAL study, ID-RCB 2009-A00833-54) will be used.
Detailed description
This study requires two steps:
- The first part of the study will be conducted on a population of 20 women free of breast cancer and, or ovarian Family (healthy volunteers controls) and without a known family history of breast and or ovarian cancer.
Mapping the level of blood (leukocytes) and the breast tissue will be drawn for the same individual on the physiological profiles splicing of the messenger RNA of genes involved in this predisposition, targeted by high-throughput sequencing of RNA (RNASeq).
A direct comparison of RNA splicing patterns between blood and breast tissue from the same witness will detect any differences between these two tissues.
-The second part of the study will be conducted on a population of 50 patients predisposed to familial breast and, or ovarian cancer compared to 20 controls with no known family history of breast and, or ovarian cancer.
Analysis of the results will highlight potential splicing abnormalities.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control population : Healthy Volunteers | Active comparator | Other: collection of a blood sample and breast and ovarian tissue20 Healthy Volunteers will be recruited: * 10 women to recover breast tissue (from surgical waste) : populations A and C * 10 women to recover ovarian tissue (from surgical waste) : population B |
| Patients | Experimental | Other: use of a previous blood collection for patientsblood samples of 50 patients will be used (use of blood collection in study EXSAL N°ID-RCB 2009-A00833-54) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- For population A
- Women without a history of breast cancer and / or ovarian cancer and no family history of breast and / or ovarian cancer among family members on the 1st and 2nd degree before age 50 for breast cancer and before age 60 for ovarian cancer
- Age 18-65 years
- Women targeted for breast reduction surgery
- Agreeing to participate in the study (collection of signed informed consent)
Key exclusion criteria (4 listed)
- Men
- Personal history (for population A and B) or family history (populations A, B, C) of breast and / or ovarian cancer (known breast or ovarian cancer in their family of 1st and 2nd degree before age 50 for breast cancer and before age 60 for ovarian cancer)
- Population C: breast cancer under 50 years
- Persons deprived of liberty or guardianship (including 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 a blood sample and breast and ovarian tissuea blood sample and a breast and ovarian tissue sample will be collected in healthy women during their surgery (breast or ovarian surgery according to selection group :A, B or C) | Other | Control population : Healthy Volunteers |
| use of a previous blood collection for patients | Other | Patients |
Primary outcome
Difference between the average rate of inclusion of exons (exon inclusion mean level) messenger RNA leucocyte of patients and the controls (without matching)
Time frame: at inclusion
1 secondary outcome
Difference between the average rate of inclusion of exons (exon inclusion mean level) leukocyte messenger RNAs and, the mRNA of breast tissue in healthy women (with pairing).
Time frame: at inclusion
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 9 Nov 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.
Sophie KRIEGER, MD principal investigator
Centre François Baclesse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collection of a blood sample and breast and ovarian tissue and use of a previous blood collection for patients in people with Breast Cancer and Transcriptomes, run by Centre Francois Baclesse 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 11 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 9 Nov 2020. 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?
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?
Difference between the average rate of inclusion of exons (exon inclusion mean level) messenger RNA leucocyte of patients and the controls (without matching) (time frame: at 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 9 Nov 2020.