NCT01797692

Brief Summary

This is a multicenter pilot study, proposed for cases and controls 3 departments in France. Cases are cured patients who have had prostate cancer for at least 10 years. Cookies are healthy subjects selected by lottery on voter list. Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

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

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 22, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 4, 2015

Status Verified

July 1, 2013

Enrollment Period

2.1 years

First QC Date

February 5, 2013

Last Update Submit

March 3, 2015

Conditions

Prostate Cancer CuredHealthy Population Control

Keywords

prostate cancer curedaged patients

Outcome Measures

Primary Outcomes (1)

  • impact of treatments

    The main objective of this study is to evaluate the impact of treatments and their effects on the autonomy of patients over 75 years have been treated and cured for prostate cancer.

    10 years after treatment for cancer prostate

Secondary Outcomes (3)

  • Evaluate the anxiety of patients and controls

    10 years after treatment for cancer prostate

  • Assessing depression patients and controls

    10 years after treatments for cancer prostate

  • Assess the nutritional status of patients and controls

    10 years after treatments for cancer prostate

Study Arms (1)

geriatric assessment

OTHER

geriatric assessment

Other: geriatric assessment

Interventions

geriatric assessmentOTHER

A single geriatric assessment with a geriatrician was proposed to patients and to control population.

geriatric assessment

Eligibility Criteria

Age75 Years+
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients aged 75 years or more
  • Patients with a personal history of prostate cancer with a diagnosis ≥ 10 years
  • Patients who received curative treatment (surgery, radiotherapy,hormone therapy, brachytherapy, technical ablative) for localized prostate cancer
  • Patients considered cured of prostate cancer (regardless of initial treatment)
  • Patients with previously agreed to participate in a case-control study in the general population (study QALIPRO) as a case and volunteer to receive an assessment of geriatric
  • Signature of consent
  • Affiliation to a social security system

You may not qualify if:

  • Patients under 75 years
  • Patients with recurrent or metastatic
  • Persons deprived of liberty or under guardianship
  • Male subjects
  • Subjects of 75 years or more
  • Subjects that do not have cancer or a history of cancer (except basal cell skin cancer)
  • Subject has previously agreed to participate in a case-control study in the general population (study QALIPRO) as a voluntary witness and to benefit from a balance oncogeriatrics
  • Subjects who gave their written consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hopitaux universitaires de Strasbourg

Strasbourg, Bas-Rhin, 67000, France

Location

Centre François BACLESSE

Caen, Calvados, 14076, France

Location

Clinique Claude BERNARD

Albi, 81000, France

Location

CHRU

Besançon, 25000, France

Location

CHIC

Castres, 81 000, France

Location

MeSH Terms

Interventions

Geriatric Assessment

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 22, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 4, 2015

Record last verified: 2013-07

Locations

FR(5)