Breast Cancer DiagnosisNCT02869607
Institut Paoli Calmettes Breast Cancer Database
An observational study of Breast Cancer Diagnosis, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
Database of Institut Paoli-Calmettes patients diagnosed with breast cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Diagnosis
- What is being tested?
- Data collection
- How many people
- 45,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 1995to Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with a diagnosis of Breat Cancer
Who may be able to join
- Patient with a diagnosis of breast cancer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, Bouches du Rhone, 13009
Dominique GENRE, MD, 33 4 91 22 37 78, drci.up@ipc.unicancer.fr
About this study
Database of Institut Paoli-Calmettes patients diagnosed with breast cancer
- Conditions
- Breast Cancer Diagnosis
- Being tested
- Data collection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with breast cancer diagnosis | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of patients with breast cancer
Overall survival of all patients who come in the center
Measured: 10 years
Secondary outcomes (1)
Collection of patients characteristics
Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startJan 1995
- Primary completionJan 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer DiagnosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869607
- Sponsor's protocol ID
- BDD-SEIN-IPC
- Status last verified
- Aug 2016
- First submitted
- 3 Aug 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Houvenaeghel G, de Nonneville A, Cohen M, Sabiani L, Buttarelli M, Charaffe E, Jalaguier A, Bannier M, Tallet A, Viret F, Goncalves A. Neoadjuvant chemotherapy for breast cancer: Pathologic response rates but not tumor size, has an independent prognostic impact on survival. Cancer Med. 2024 Feb;13(3):e6930. doi: 10.1002/cam4.6930. Epub 2024 Feb 7.
PubMed 38327130Houvenaeghel G, de Nonneville A, Cohen M, Chopin N, Coutant C, Reyal F, Mazouni C, Gimbergues P, Azuar AS, Chauvet MP, Classe JM, Darai E, Martinez A, Rouzier R, de Lara CT, Lambaudie E, Barrou J, Goncalves A. Lack of prognostic impact of sentinel node micro-metastases in endocrine receptor-positive early breast cancer: results from a large multicenter cohort☆. ESMO Open. 2021 Jun;6(3):100151. doi: 10.1016/j.esmoop.2021.100151. Epub 2021 May 10.
PubMed 33984674
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Institut Paoli Calmettes Breast Cancer Database
- ClinicalTrials.gov ID
- NCT02869607
- Acronym / sponsor ID
- BDD-SEIN-IPC
- Conditions
- Breast Cancer Diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45,000 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Jan 1995
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 17 Aug 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.
Database of Institut Paoli-Calmettes patients diagnosed with breast cancer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with breast cancer diagnosis | – | Other: Data collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of Breat Cancer
Key inclusion criteria (1 listed)
- Patient with a diagnosis of breast cancer
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Data collection | Other | Patients with breast cancer diagnosis |
Primary outcome
Survival of patients with breast cancer
Time frame: 10 years
Overall survival of all patients who come in the center
1 secondary outcome
Collection of patients characteristics
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Derived from this study: PubMed 38327130Houvenaeghel G, de Nonneville A, Cohen M, Sabiani L, Buttarelli M, Charaffe E, Jalaguier A, Bannier M, Tallet A, Viret F, Goncalves A. Neoadjuvant chemotherapy for breast cancer: Pathologic response rates but not tumor size, has an independent prognostic impact on survival. Cancer Med. 2024 Feb;13(3):e6930. doi: 10.1002/cam4.6930. Epub 2024 Feb 7.
- Derived from this study: PubMed 33984674Houvenaeghel G, de Nonneville A, Cohen M, Chopin N, Coutant C, Reyal F, Mazouni C, Gimbergues P, Azuar AS, Chauvet MP, Classe JM, Darai E, Martinez A, Rouzier R, de Lara CT, Lambaudie E, Barrou J, Goncalves A. Lack of prognostic impact of sentinel node micro-metastases in endocrine receptor-positive early breast cancer: results from a large multicenter cohort☆. ESMO Open. 2021 Jun;6(3):100151. doi: 10.1016/j.esmoop.2021.100151. Epub 2021 May 10.
- 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.
1 site 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 Diagnosis, 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 1 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: looking for participants now, as of the sponsor's last update on 17 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique Genre, MD (0033491223778, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of patients with breast cancer (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02869607, which also lists 2 linked publications.
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 17 Aug 2016.