Evaluation of Anatomy, Clinical and Neuropsychological Lo... | NCT02791360

Studies
Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor

NCT02791360

Sponsor

Centre Francois Baclesse

Status

Completed

Last Update Posted

Jan 26, 2018Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Brain Neoplasms

Interventions

Brain MRI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Sep 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

May 17, 2016

First Submission Date that Met QC Criteria

Jun 3, 2016

First Posted Date

Jun 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2018

Last Update Posted Date

Jan 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Label	Type	Description	Intervention Names
MRI evaluation	Other	Patient pretreated for brain tumor and witness	Other: Brain MRI

Name	Type	Description	Arm Group Labels	Other Names
Brain MRI	Other		MRI evaluation

Measure	Description	Time Frame
Proportion of patient with MRI abnormality	To evaluate the proportion of patients with at least one abnormality on an imaging test	up to 4 weeks

Measure	Description	Time Frame
MRI diffusion abnormality		up to 4 weeks
MRI perfusion abnormality		up to 4 weeks
MRI vascular morphologic abnormalities

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In the case group:

A history of solid brain tumor or haematological histologically proven.
Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).
Radiotherapy treatment on a tumor in place or operated.
Decline at least 10 years from the end of radiotherapy.
Treatment with isocentric conformal radiotherapy.
No other radiation therapy for locally recurrent brain metastases or new brain tumor.
Lack of known brain metastases or meningeal carcinomatosis.

For the control group:

Patients previously treated for cancer and disease relapse free for 10 years.
No brain radiotherapy treatment.
Lack of treatment with anti-cancer chemotherapy.
Women of childbearing potential must be under effective contraception.
Pairing according to age, sex, arms director and socio-cultural level.

For two groups:

Man or woman aged (e) of minimum 18 years.
Topic fluent French and comprising well.
Free and Informed Consent signed.
The subject should be affiliated to an appropriate social security system
No cons-indication to MRI.
The subject must have at least one primary school level

Exclusion Criteria:

In the case group:

Brain radiotherapy carried out by intensity modulation technique.
Radiation dose less than 36 Gy on the brain.
Subject with against-indication to MRI.

For the control group:

Previous history of brain radiotherapy.
Previous history of brain surgery.
Central neurological disorders, such as seizures, uncontrolled.

For two groups:

Current Topics in oral chemotherapy or intravenous.
Subject pregnant.
Subject is not fluent in French or including bad.
Any geographical conditions, social or associated psychopathology that could compromise the patient's ability to participate in the study.
Participation in a therapeutic trial for less than 30 days.
A person not affiliated with a social security scheme.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms