Breast CancerONCO S-ONCT02910622
Pilot Study Evaluating the Oncogramme: Analysis of Response to Induction Treatment of Patients With Breast or Ovarian Cancer.
An observational study of Breast Cancer and Ovarian Cancer, run by University Hospital, Limoges at 2 sites in France.
Trial summary
The choice of treatments for cancers by systemic way - chemotherapy, hormone therapy and targeted therapies - is currently defined by criteria for population groups and not to an individual. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Cancer
- What is being tested?
- Chimio-oncogramme
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2012to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with breast cancer needed starting an induction therapy neo-adjuvant or metastatic but inoperable position (isolated bone metastases, skin permeation nodule). And patient diagnosed with ovarian cancer before starting an induction treatment stage IIIc and IV pleural IFGO (International federation of gynecology obstetric) operable.
Who may be able to join
- Age of at least 18 years.
- Patient with breast cancer needed starting an induction therapy or neo-adjuvant or metastatic but inoperable position (isolated bone metastases, skin permeation nodule).
- Patient Diagnosed with ovarian cancer before starting an induction treatment stage IIIc and IV pleural IFGO operable.
- Measurable disease according to RECIST 1.1 criteria by Magnetic resonance imaging (MRI), tomodensitometry scan or assessable by positron emission tomography scan (PET-SCAN) according to European Organisation for Research and Treatment of Cancer (EORTC) or Chevallier criteria and / or Sataloff post-neo adjuvant for breast or assessable during surgery for carcinomatosis by score Sugarbaker
- Patient has not expressed opposition to the use of their residual tumor
- Lack of cancer within 5 years with the exception of basal cell carcinoma or squamous cell cancer or in situ cervix Treaty
- Patients not included in a therapeutic trial with an experimental molecule in the indication concerned.
Who cannot join
- Lack of contraception for women of childbearing age
- Use of targeted therapy, hormone therapy, radiation therapy concomitantly
- Inability to submit to monitoring for geographical, social or psychological reasons
- Nobody deprived of liberty by administrative or judicial decision or person under guardianship.
- Difficulty understanding of the Protocol
- Social uninsured patient
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital
Bordeaux, 33000
University Hospital
Limoges, 87042
About this study
The choice of treatments for cancers by systemic way - chemotherapy, hormone therapy and targeted therapies - is currently defined by criteria for population groups and not to an individual. These expensive treatments - in financial terms and quality of life - will be effective for some and administered unnecessarily for other because there is no predictive test of response for a given individual.
For breast cancer, the usual treatment includes the first surgery and adjuvant therapies (chemotherapy, hormonal therapy ...) whose effectiveness will be assessed after many years as the occurrence or not of a recurrence or metastases.
Read more
These systemic treatments can also be administered before surgery to reduce the tumor volume and secondarily allow less mutilating surgery: it is the principle of treatment neo adjuvant. In this case, the efficiency will be evaluated more quickly.
In practice, a patient with breast cancer suspicion has a biopsy which confirms the diagnosis and defined the parameters (hormone receptors, cytological grade, receptor monoclonal antibodies ...) that guide to the most appropriate type of treatment.
Tumor size is evaluated in neo adjuvant pre-treatment by imaging: mammography, ultrasound and MRI.
At the end of this medication, the evaluation of the response is achieved by radiology and surgery.
Pathological examination evaluates and precise response by the criteria of Chevallier and / or Sataloff. An ex vivo test for predicting the response of cells to different chemotherapy regimens, the oncogramme, was developed by Oncomedics, a young company whose technology is derived from the University of Limoges.
Clinical response and / or histopathological could be compared in a reasonable time (2-6 months), the results of the oncogramme proposed by Oncomedics whether the efficiency obtained in vivo is that predicted by the ex vivo test.
It is the same in the metastatic setting when there is an available target for biopsy and assessment of response.
The management of ovarian cancer in advanced stages can also benefit from a radiological and histopathological evaluation strategy before and after systemic treatment to compare the in vivo results with those predicted by ex vivo by Oncomedics.
Read the detailed description
A fragment of Breast/Ovarian tumors will be taken from a specimen or a cold biopsy, tissue from patients diagnosed with breast cancer or ovarian cancer before starting an induction treatment stage IIIc and IV pleural IFGO operable.
- Culturing the cells obtained from the tumor fragment by Oncomedics in a defined medium and provided for enriching tumor cells compared to stromal cells.
- Maintaining the cells in culture for 7 days.
- Effects of conventional chemotherapy (corresponding to protocols) on these cells for 72 hours (growth chambers) by Oncomedics (chimio-oncogramme).
- For each chemotherapy tested, measuring the proportion of dead cells / total cells.
- Retained by Oncomedics results, not given to the nursing team. The patient will be treated and followed up in the usual way.
- At the end of the study, comparing the in vitro results (chimio-oncogramme) to the patient response to the same chemotherapy.
- Conditions
- Breast Cancer, Ovarian Cancer
- Being tested
- Chimio-oncogramme
- Keywords
- breast, ovarian, cancer
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimio-oncogrammeOther
Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.
| Study group | Role | What they receive |
|---|---|---|
| Oncogramme breast | Taking a fragment of breast tumors taken from a specimen. Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme Receives: Other: Chimio-oncogramme | |
| Oncogramme ovarian | Taking a fragment of ovarian tumors taken from a specimen. Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme Receives: Other: Chimio-oncogramme |
What is being measured
The primary outcome is the main question the study is designed to answer.
In vitro analysis of chemotherapy responses
Evaluate the predictive value of chemo-oncogramme on the patients response to the same (s) chemotherapy (s)
Measured: Days 7
Secondary outcomes (1)
Radiological Evaluation of the in vivo response
Radiological Evaluation of the in vivo response by RECIST or EORTC criteria
Measured: Days 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startJun 2012
- Primary completionJun 2016
- Study completionJun 2016
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.
- More trials run by University Hospital, LimogesThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910622
- Sponsor's protocol ID
- I09018 (ONCOGRAMME S-O)
- Acronym
- ONCO S-O
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Oncogramme: Analysis of Response to Induction Treatment of Patients With Breast or Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT02910622
- Acronym / sponsor ID
- ONCO S-O / I09018 (ONCOGRAMME S-O)
- Conditions
- Breast Cancer, Ovarian Cancer
- Keywords
- breast, ovarian, cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Sep 2016 (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.
The choice of treatments for cancers by systemic way - chemotherapy, hormone therapy and targeted therapies - is currently defined by criteria for population groups and not to an individual. These expensive treatments - in financial terms and quality of life - will be effective for some and administered unnecessarily for other because there is no predictive test of response for a given individual.
For breast cancer, the usual treatment includes the first surgery and adjuvant therapies (chemotherapy, hormonal therapy ...) whose effectiveness will be assessed after many years as the occurrence or not of a recurrence or metastases.
These systemic treatments can also be administered before surgery to reduce the tumor volume and secondarily allow less mutilating surgery: it is the principle of treatment neo adjuvant. In this case, the efficiency will be evaluated more quickly.
In practice, a patient with breast cancer suspicion has a biopsy which confirms the diagnosis and defined the parameters (hormone receptors, cytological grade, receptor monoclonal antibodies ...) that guide to the most appropriate type of treatment.
Tumor size is evaluated in neo adjuvant pre-treatment by imaging: mammography, ultrasound and MRI.
At the end of this medication, the evaluation of the response is achieved by radiology and surgery.
Pathological examination evaluates and precise response by the criteria of Chevallier and / or Sataloff. An ex vivo test for predicting the response of cells to different chemotherapy regimens, the oncogramme, was developed by Oncomedics, a young company whose technology is derived from the University of Limoges.
Clinical response and / or histopathological could be compared in a reasonable time (2-6 months), the results of the oncogramme proposed by Oncomedics whether the efficiency obtained in vivo is that predicted by the ex vivo test.
It is the same in the metastatic setting when there is an available target for biopsy and assessment of response.
The management of ovarian cancer in advanced stages can also benefit from a radiological and histopathological evaluation strategy before and after systemic treatment to compare the in vivo results with those predicted by ex vivo by Oncomedics.
Detailed description
A fragment of Breast/Ovarian tumors will be taken from a specimen or a cold biopsy, tissue from patients diagnosed with breast cancer or ovarian cancer before starting an induction treatment stage IIIc and IV pleural IFGO operable.
- Culturing the cells obtained from the tumor fragment by Oncomedics in a defined medium and provided for enriching tumor cells compared to stromal cells.
- Maintaining the cells in culture for 7 days.
- Effects of conventional chemotherapy (corresponding to protocols) on these cells for 72 hours (growth chambers) by Oncomedics (chimio-oncogramme).
- For each chemotherapy tested, measuring the proportion of dead cells / total cells.
- Retained by Oncomedics results, not given to the nursing team. The patient will be treated and followed up in the usual way.
- At the end of the study, comparing the in vitro results (chimio-oncogramme) to the patient response to the same chemotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oncogramme breast | – | Other: Chimio-oncogrammeTaking a fragment of breast tumors taken from a specimen. Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme |
| Oncogramme ovarian | – | Other: Chimio-oncogrammeTaking a fragment of ovarian tumors taken from a specimen. Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with breast cancer needed starting an induction therapy neo-adjuvant or metastatic but inoperable position (isolated bone metastases, skin permeation nodule). And patient diagnosed with ovarian cancer before starting an induction treatment stage IIIc and IV pleural IFGO (International federation of gynecology obstetric) operable.
Key inclusion criteria (7 listed)
- Age of at least 18 years.
- Patient with breast cancer needed starting an induction therapy or neo-adjuvant or metastatic but inoperable position (isolated bone metastases, skin permeation nodule).
- Patient Diagnosed with ovarian cancer before starting an induction treatment stage IIIc and IV pleural IFGO operable.
- Measurable disease according to RECIST 1.1 criteria by Magnetic resonance imaging (MRI), tomodensitometry scan or assessable by positron emission tomography scan (PET-SCAN) according to European Organisation for Research and Treatment of Cancer (EORTC) or Chevallier criteria and / or Sataloff post-neo adjuvant for breast or assessable during surgery for carcinomatosis by score Sugarbaker
- Patient has not expressed opposition to the use of their residual tumor
Key exclusion criteria (6 listed)
- Lack of contraception for women of childbearing age
- Use of targeted therapy, hormone therapy, radiation therapy concomitantly
- Inability to submit to monitoring for geographical, social or psychological reasons
- Nobody deprived of liberty by administrative or judicial decision or person under guardianship.
- Difficulty understanding of the Protocol
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 |
|---|---|---|
| Chimio-oncogrammeCells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme. | Other | Oncogramme breast, Oncogramme ovarian |
Primary outcome
In vitro analysis of chemotherapy responses
Time frame: Days 7
Evaluate the predictive value of chemo-oncogramme on the patients response to the same (s) chemotherapy (s)
1 secondary outcome
Radiological Evaluation of the in vivo response
Time frame: Days 7
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 23 Sep 2016.
- 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. 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?
An observational study of Breast Cancer and Ovarian Cancer, run by University Hospital, Limoges 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 7 inclusion and 6 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 23 Sep 2016. 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?
In vitro analysis of chemotherapy responses (time frame: Days 7). 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 23 Sep 2016.