Medical and Surgical Management of Patients With Brain Metastases

NCT03981016 | Completed

• 1 other identifier: ICM-URC-2014/21
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 12

Brief Summary

The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

Conditions

Central Nervous System Tumor

Keywords

Nervous; Central; Tumor; System

Outcome Measures

Primary Outcomes (4)

• Number of patients who had a histological study of their brain metastases

  24 months

• Number of patients who had a neurosurgery of their brain metastases

  24 months

• Number of patients who had a radiotherapy of their brain metastases

  24 months

• Number of patients who had a chemotherapy of their brain metastases

  24 months

Secondary Outcomes (4)

• Quality of life by using the quality of life questionnaire core (QLQ-C30).

  24 months

• Quality of life by using the quality of life questionnaire - brain neoplasm (BN20)

  24 months

• Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)

  24 months

• Overall Survival

  Approximately 48 months

Study Arms (1)

Biological collection

EXPERIMENTAL

For the patients include in the study : * blood samples collected at different times : Before surgery and during the post-operative visit and * frozen tumor samples and / or paraffin samples at the time of surgery and- paraffin around tumor samples at the time of surgery

Other: Biological collection

Interventions

Biological collection OTHER

* blood samples collected at different times : Before surgery and during the post-operative visit and * frozen tumor samples and / or paraffin samples at the time of surgery and- paraffin around tumor samples at the time of surgery

Biological collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥ 18 years
• Radiological diagnosis of brain metastases
• Patient eligible for neurosurgical exeresis or treatment by radio-surgery
• Patient treated in a neurosurgery center of the Languedoc-Roussillon region (whatever therapeutic treatment realized on primary tumor)
• Present brain metastases not previously treated
• Signed informed consent
• Patient affiliated to a national insurance system or beneficiary of such a system

You may not qualify if:

• Patient with primary brain tumor
• Impossibility to be regularly monitored for psychological, family, social, or geographical reasons
• Subject under guardianship

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (12)

Centre hospitalier régional et universitaire de Nîmes

Nîmes, Gard, 30000, France

Location

Centre médical Oncogard

Nîmes, Gard, 30000, France

Location

Clinique les Franciscaines

Nîmes, Gard, 30000, France

Location

Laboratoire d'anatomo-pathologie de Nîmes

Nîmes, Gard, 30000, France

Location

Centre médical Oncodoc Béziers

Béziers, Hérault, 34000, France

Location

Centre d'Anatomie et Cytologie Pathologiques de Grabels

Grabels, Hérault, 34000, France

Location

Centre hospitalier régional et universitaire de Montpellier

Montpellier, Hérault, 34000, France

Location

Clinique Clémentville

Montpellier, Hérault, 34000, France

Location

Clinique du Millénaire

Montpellier, Hérault, 34000, France

Location

Institut régional du cancer

Montpellier, Hérault, 34298, France

Location

Centre hospitalier de Perpignan

Perpignan, Pyrénées-orientales, 66000, France

Location

Clinique Saint-Pierre

Perpignan, Pyrénées-orientales, 66000, France

Location

Related Publications (4)

• Davis FG, Dolecek TA, McCarthy BJ, Villano JL. Toward determining the lifetime occurrence of metastatic brain tumors estimated from 2007 United States cancer incidence data. Neuro Oncol. 2012 Sep;14(9):1171-7. doi: 10.1093/neuonc/nos152. Epub 2012 Aug 16.

  PMID: 22898372 BACKGROUND

• Fox BD, Cheung VJ, Patel AJ, Suki D, Rao G. Epidemiology of metastatic brain tumors. Neurosurg Clin N Am. 2011 Jan;22(1):1-6, v. doi: 10.1016/j.nec.2010.08.007.

  PMID: 21109143 BACKGROUND

• Smedby KE, Brandt L, Backlund ML, Blomqvist P. Brain metastases admissions in Sweden between 1987 and 2006. Br J Cancer. 2009 Dec 1;101(11):1919-24. doi: 10.1038/sj.bjc.6605373. Epub 2009 Oct 13.

  PMID: 19826419 BACKGROUND

• Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.

  PMID: 21041710 BACKGROUND

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Study Officials

• Luc Bauchet, MD

  Centre hospitalier de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: March 2, 2015
• Primary Completion: January 19, 2018
• Study Completion: August 31, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)