NCT03461172

Brief Summary

For several years, the Paoli-Calmettes Institute has been centralizing the retrospective collection of clinical data of patients operated on for histologically proven breast cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2006

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 24, 2018

Status Verified

March 1, 2018

Enrollment Period

20 years

First QC Date

March 5, 2018

Last Update Submit

May 23, 2018

Conditions

Surgery of Breast Cancer

Keywords

surgerybreast cancer

Outcome Measures

Primary Outcomes (1)

  • follow-up of patients operated for breast cancer

    20 years

Study Arms (1)

patients operated for breast cancer

patients operated for histologically proven breast cancer

Procedure: Surgery of breast cancerOther: Clinical data collection

Interventions

Surgery of breast cancerPROCEDURE

Surgery of breast cancer

patients operated for breast cancer
Clinical data collectionOTHER

The collection centralizes the main characteristics of the patients, the tumor and the treatments. Also included are the date of first recurrence, the localization (local, regional or distant) as well as the death or the date of the latest news.

patients operated for breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Database of data collection in senological surgery

You may qualify if:

  • patients operated for histologically proven breast cancer.

You may not qualify if:

  • Patient below age of 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

RECRUITING

Related Publications (15)

  • Houvenaeghel G, Lambaudie E, Cohen M, Classe JM, Reyal F, Garbay JR, Giard S, Chopin N, Martinez A, Rouzier R, Darai E, Colombo PE, Coutant C, Gimbergues P, Azuar P, Villet R, Tunon de Lara C, Barranger E, Sabiani L, Goncalves A. Therapeutic escalation - De-escalation: Data from 15.508 early breast cancer treated with upfront surgery and sentinel lymph node biopsy (SLNB). Breast. 2017 Aug;34:24-33. doi: 10.1016/j.breast.2017.04.008. Epub 2017 May 3.

    PMID: 28475932RESULT

  • de Nonneville A, Goncalves A, Zemmour C, Classe JM, Cohen M, Lambaudie E, Reyal F, Scherer C, Muracciole X, Colombo PE, Giard S, Rouzier R, Villet R, Chopin N, Darai E, Garbay JR, Gimbergues P, Sabiani L, Coutant C, Sabatier R, Bertucci F, Boher JM, Houvenaeghel G. Benefit of adjuvant chemotherapy with or without trastuzumab in pT1ab node-negative human epidermal growth factor receptor 2-positive breast carcinomas: results of a national multi-institutional study. Breast Cancer Res Treat. 2017 Apr;162(2):307-316. doi: 10.1007/s10549-017-4136-5. Epub 2017 Feb 2.

    PMID: 28155054RESULT

  • Lambaudie E, Houvenaeghel G, Zioueche A, Knight S, Dravet F, Garbay JR, Giard S, Charitansky H, Cohen M, Faure C, Hudry D, Azuar P, Villet R, Gimbergues P, de Lara CT, Tallet A, Bannier M, Minsat M, Resbeut M. Exclusive intraoperative radiotherapy for invasive breast cancer in elderly patients (>70 years): proportion of eligible patients and local recurrence-free survival. BMC Surg. 2016 Nov 15;16(1):74. doi: 10.1186/s12893-016-0191-9.

    PMID: 27846840RESULT

  • Houvenaeghel G, Sabatier R, Reyal F, Classe JM, Giard S, Charitansky H, Rouzier R, Faure C, Garbay JR, Darai E, Hudry D, Gimbergues P, Villet R, Lambaudie E. Axillary lymph node micrometastases decrease triple-negative early breast cancer survival. Br J Cancer. 2016 Oct 25;115(9):1024-1031. doi: 10.1038/bjc.2016.283. Epub 2016 Sep 29.

    PMID: 27685443RESULT

  • Houvenaeghel G, Boher JM, Reyal F, Cohen M, Garbay JR, Classe JM, Rouzier R, Giard S, Faure C, Charitansky H, Tunon de Lara C, Darai E, Hudry D, Azuar P, Gimbergues P, Villet R, Sfumato P, Lambaudie E. Impact of completion axillary lymph node dissection in patients with breast cancer and isolated tumour cells or micrometastases in sentinel nodes. Eur J Cancer. 2016 Nov;67:106-118. doi: 10.1016/j.ejca.2016.08.003. Epub 2016 Sep 16.

    PMID: 27640137RESULT

  • Sabiani L, Houvenaeghel G, Heinemann M, Reyal F, Classe JM, Cohen M, Garbay JR, Giard S, Charitansky H, Chopin N, Rouzier R, Darai E, Coutant C, Azuar P, Gimbergues P, Villet R, Tunon de Lara C, Lambaudie E. Breast cancer in young women: Pathologic features and molecular phenotype. Breast. 2016 Oct;29:109-16. doi: 10.1016/j.breast.2016.07.007. Epub 2016 Jul 29.

    PMID: 27479041RESULT

  • Houvenaeghel G, Classe JM, Garbay JR, Giard S, Cohen M, Faure C, Charytansky H, Rouzier R, Darai E, Hudry D, Azuar P, Villet R, Gimbergues P, Tunon de Lara C, Martino M, Fraisse J, Dravet F, Chauvet MP, Goncalves A, Lambaudie E. Survival impact and predictive factors of axillary recurrence after sentinel biopsy. Eur J Cancer. 2016 May;58:73-82. doi: 10.1016/j.ejca.2016.01.019. Epub 2016 Mar 11.

    PMID: 26971077RESULT

  • Jauffret C, Houvenaeghel G, Classe JM, Garbay JR, Giard S, Charitansky H, Cohen M, Belichard C, Faure C, Darai E, Hudry D, Azuar P, Villet R, Gimbergues P, Tunon de Lara C, Martino M, Coutant C, Dravet F, Chauvet MP, Chereau Ewald E, Penault-Llorca F, Goncalves A, Lambaudie E. [Lobular invasive breast cancer prognostic factors: About 940 patients]. Gynecol Obstet Fertil. 2015 Nov;43(11):712-7. doi: 10.1016/j.gyobfe.2015.09.007. Epub 2015 Oct 16. French.

    PMID: 26482833RESULT

  • Zioueche-Mottet A, Houvenaeghel G, Classe JM, Garbay JR, Giard S, Charitansky H, Cohen M, Belichard C, Faure C, Chereau Ewald E, Hudry D, Azuar P, Villet R, Gimbergues P, Tunon de Lara C, Tallet A, Bannier M, Minsat M, Lambaudie E, Resbeut M. Eligibility criteria for intraoperative radiotherapy for breast cancer: study employing 12,025 patients treated in two cohorts. BMC Cancer. 2014 Nov 24;14:868. doi: 10.1186/1471-2407-14-868.

    PMID: 25417756RESULT

  • Houvenaeghel G, Classe JM, Garbay JR, Giard S, Cohen M, Faure C, Helene C, Belichard C, Uzan S, Hudry D, Azuar P, Villet R, Penault Llorca F, Tunon de Lara C, Goncalves A, Esterni B; et al. Prognostic value of isolated tumor cells and micrometastases of lymph nodes in early-stage breast cancer: a French sentinel node multicenter cohort study. Breast. 2014 Oct;23(5):561-6. doi: 10.1016/j.breast.2014.04.004. Epub 2014 May 27.

    PMID: 24874284RESULT

  • Houvenaeghel G, Goncalves A, Classe JM, Garbay JR, Giard S, Charytensky H, Cohen M, Belichard C, Faure C, Uzan S, Hudry D, Azuar P, Villet R, Gimbergues P, Tunon de Lara C, Martino M, Lambaudie E, Coutant C, Dravet F, Chauvet MP, Chereau Ewald E, Penault-Llorca F, Esterni B. Characteristics and clinical outcome of T1 breast cancer: a multicenter retrospective cohort study. Ann Oncol. 2014 Mar;25(3):623-628. doi: 10.1093/annonc/mdt532. Epub 2014 Jan 7.

    PMID: 24399079RESULT

  • Houvenaeghel G, Bannier M, Nos C, Giard S, Mignotte H, Jacquemier J, Martino M, Esterni B, Belichard C, Classe JM, Tunon de Lara C, Cohen M, Payan R, Blanchot J, Rouanet P, Penault-Llorca F, Bonnier P, Fournet S, Agostini A, Marchal F, Garbay JR. Non sentinel node involvement prediction for sentinel node micrometastases in breast cancer: nomogram validation and comparison with other models. Breast. 2012 Apr;21(2):204-9. doi: 10.1016/j.breast.2011.09.013. Epub 2011 Oct 19.

    PMID: 22014859RESULT

  • Houvenaeghel G, Nos C, Giard S, Mignotte H, Esterni B, Jacquemier J, Buttarelli M, Classe JM, Cohen M, Rouanet P, Penault Llorca F, Bonnier P, Marchal F, Garbay JR, Fraisse J, Martel P, Fondrinier E, Tunon de Lara C, Rodier JF. A nomogram predictive of non-sentinel lymph node involvement in breast cancer patients with a sentinel lymph node micrometastasis. Eur J Surg Oncol. 2009 Jul;35(7):690-5. doi: 10.1016/j.ejso.2008.10.003. Epub 2008 Nov 28.

    PMID: 19046847RESULT

  • Houvenaeghel G, Nos C, Mignotte H, Classe JM, Giard S, Rouanet P, Lorca FP, Jacquemier J, Bardou VJ; Groupe des Chirurgiens de la Federation des Centres de Lutte Contre le Cancer. Micrometastases in sentinel lymph node in a multicentric study: predictive factors of nonsentinel lymph node involvement--Groupe des Chirurgiens de la Federation des Centres de Lutte Contre le Cancer. J Clin Oncol. 2006 Apr 20;24(12):1814-22. doi: 10.1200/JCO.2005.03.3225. Epub 2006 Mar 27.

    PMID: 16567771RESULT

  • Houvenaeghel G, de Nonneville A, Chopin N, Classe JM, Mazouni C, Chauvet MP, Reyal F, Tunon de Lara C, Jouve E, Rouzier R, Darai E, Gimbergues P, Coutant C, Azuar AS, Villet R, Crochet P, Rua S, Bannier M, Cohen M, Boher JM. The need to tailor the omission of axillary lymph node dissection to patients with good prognosis and sentinel node micro-metastases. Cancer Med. 2023 Feb;12(4):4023-4032. doi: 10.1002/cam4.5257. Epub 2022 Sep 20.

    PMID: 36127853DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Gilles HOUVENAEGHEL

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles HOUVENAEGHEL

CONTACT

HOUVENAEGHELG@ipc.unicancer.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 9, 2018

Study Start

April 20, 2006

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

May 24, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)