Breast CancerMAMMOSITE2NCT00922961
Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
A study testing Blood sample and Clinical exam in people with Breast Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial summary
25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy. During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis) Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood sample and Clinical exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Feb 2009
- 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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patient treated by exclusive per-operative brachytherapy in the prior study Mammosite for breast cancer
- Patient with social security
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.
During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)
Read the detailed description
This is an interventional study for the french law
- Conditions
- Breast Cancer
- Being tested
- Blood sample, Clinical exam
- Keywords
- brachytherapy, late cutaneous toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis
Clinical examProcedure or surgery
Assessment of the esthetic score, and the late cutaneous side effect by 2 physicians
| Study group | Role | What they receive |
|---|---|---|
| cellular apoptosis | Experimental | Not described Receives: Biological: Blood sample; Procedure: Clinical exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis
Measured: Blood sample during a consultation
Secondary outcomes (5)
Assessment of the rate and scores of late fibrosis related to irradiation by mammosite
Measured: During a consultation with 2 physicians
Assessment of the rate of telangiectasia
Measured: During a consultation with 2 physicians
Assessment of the rate of sequellar pain
Measured: During a consultation with 2 physicians
Assessment of the rate of seroma collection
Measured: During a consultation with 2 physicians
Assessment of the breast esthetic score
Measured: During a consultation with 2 physicians
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startSep 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yazid BELKACEMI, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922961
- Sponsor's protocol ID
- MAMMOSITE2
- Acronym
- MAMMOSITE2
- Status last verified
- Jul 2012
- First submitted
- 15 Jun 2009
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT00922961
- Acronym / sponsor ID
- MAMMOSITE2 / MAMMOSITE2
- Conditions
- Breast Cancer
- Keywords
- brachytherapy, late cutaneous toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 17 Jun 2009 (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.
25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.
During this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)
Detailed description
This is an interventional study for the french law
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cellular apoptosis | Experimental | Biological: Blood sample, Procedure: Clinical exam |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patient treated by exclusive per-operative brachytherapy in the prior study Mammosite for breast cancer
- Patient with social security
Key exclusion criteria (1 listed)
- Not applicable
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 sampleBlood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis | Biological | cellular apoptosis |
| Clinical examAssessment of the esthetic score, and the late cutaneous side effect by 2 physicians | Procedure or surgery | cellular apoptosis |
Primary outcome
Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis
Time frame: Blood sample during a consultation
5 secondary outcomes
Assessment of the rate and scores of late fibrosis related to irradiation by mammosite
Time frame: During a consultation with 2 physicians
Assessment of the rate of telangiectasia
Time frame: During a consultation with 2 physicians
Assessment of the rate of sequellar pain
Time frame: During a consultation with 2 physicians
Assessment of the rate of seroma collection
Time frame: During a consultation with 2 physicians
Assessment of the breast esthetic score
Time frame: During a consultation with 2 physicians
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 Jul 2012.
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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.
Yazid BELKACEMI, MD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Clinical exam in people with Breast Cancer, run by Centre Oscar Lambret 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 2 inclusion and 1 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 Jul 2012. 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?
Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis (time frame: Blood sample during a consultation). 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 Jul 2012.