Hodgkin DiseasePROPERNCT01188915
Personalised Program for Women Treated for Hodgkin Disease
A study testing intensive screening in people with Hodgkin Disease and Breast Cancer, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by treatment, are the first cause of death. The investigators will estimate the risk to develop breast cancer in this population of women treated for hodgkin disease, and will propose women at high rish to participate in an… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hodgkin Disease, Breast Cancer
- What is being tested?
- intensive screening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2010to Jul 2026
- 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
- women > 18 years
- treated for Hodgkin disease
- signed informed consent
- high risk of breast cancer
Who cannot join
- patients unable to have a regular follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalised Program for Women Treated for Hodgkin Disease : Risk Evaluation of Breast Cancer and Intensive Screening Program for Women at High Risk of Breast Cancer. PROPER/IPC 2010-001
After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by treatment, are the first cause of death.
The investigators will estimate the risk to develop breast cancer in this population of women treated for hodgkin disease, and will propose women at high rish to participate in an intensive screening program based on an annual detection based on mammography, echography, and RMI.
- Conditions
- Hodgkin Disease, Breast Cancer
- Being tested
- intensive screening
- Keywords
- Hodgkin disease, Breast cancer
- Medical subject headings
- Hodgkin Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive screeningProcedure or surgery
Each year, women will have breast cancer detection based on mammography, echography and RMI. Questionaries will also be completed.
| Study group | Role | What they receive |
|---|---|---|
| intensive screening | Experimental | annual breast cancer detection based on mammography, echography and RMI. Receives: Procedure: intensive screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of the screening
The efficacy of the screening will be evaluated by the rate of early stage breast cancer detected. The rate of in situ, < 10 mm(T1b), and N0 will be estimated.
Measured: 15 years
Secondary outcomes (4)
interest
The rate of interest is the % of women at high risk who will accept the intensive screening
Measured: 1 month
adhesion
The adhesion rate is the % of women who will effectively undergo the first screnning among the women who had accepted their participation in this intensive screening
Measured: 1 month
compliance
The compliance will be evaluated yearly. The number of exam realised compared to the theoric number and the time between 2 exams will be estimated.
Measured: 15 years
psychologic impact
The psychologic impact will be assessed yearly by questionnaries evaluating quality of life, anxiety and satisfaction.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2016
- Study completionJul 2026 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François EISINGER, PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188915
- Sponsor's protocol ID
- PROPER/IPC 2010-001
- Acronym
- PROPER
- Status last verified
- Aug 2016
- First submitted
- 24 Aug 2010
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Program for Women Treated for Hodgkin Disease : Risk Evaluation of Breast Cancer and Intensive Screening Program for Women at High Risk of Breast Cancer. PROPER/IPC 2010-001
- ClinicalTrials.gov ID
- NCT01188915
- Acronym / sponsor ID
- PROPER / PROPER/IPC 2010-001
- Conditions
- Hodgkin Disease, Breast Cancer
- Keywords
- Hodgkin disease, Breast cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Aug 2010 (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.
After treatment for Hodgkin disease, secondary cancer, in particular breast cancer induced by treatment, are the first cause of death.
The investigators will estimate the risk to develop breast cancer in this population of women treated for hodgkin disease, and will propose women at high rish to participate in an intensive screening program based on an annual detection based on mammography, echography, and RMI.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intensive screening | Experimental | Procedure: intensive screeningannual breast cancer detection based on mammography, echography and RMI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women > 18 years
- treated for Hodgkin disease
- signed informed consent
- high risk of breast cancer
Key exclusion criteria (1 listed)
- patients unable to have a regular follow-up
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 |
|---|---|---|
| intensive screeningEach year, women will have breast cancer detection based on mammography, echography and RMI. Questionaries will also be completed. | Procedure or surgery | intensive screening |
Primary outcome
efficacy of the screening
Time frame: 15 years
The efficacy of the screening will be evaluated by the rate of early stage breast cancer detected. The rate of in situ, < 10 mm(T1b), and N0 will be estimated.
4 secondary outcomes
interest
Time frame: 1 month
adhesion
Time frame: 1 month
compliance
Time frame: 15 years
psychologic impact
Time frame: 15 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
- institut Paoli-Calmettes web siteLink provided by the sponsor.
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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.
François EISINGER, PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive screening in people with Hodgkin Disease and Breast Cancer, run by Institut Paoli-Calmettes 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 4 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: stopped early, as of the sponsor's last update on 14 Oct 2016. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
efficacy of the screening (time frame: 15 years). 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 14 Oct 2016.