- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01797692
Study of Geriatric Patients Aged 75 Years or Older Treated and Cured for Localized Prostate Cancer: Case-control Study (PROGE)
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.
연구 개요
상세 설명
Volunteer subjects (cases and controls) are offered a consultation and assessment with an geriatrician.
During this consultation, ADL, IADL and MMS questionnary will be completed. neurocognitif testing will be done.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
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Albi, 프랑스, 81000
- Clinique Claude Bernard
-
Besancon, 프랑스, 25000
- CHRU
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Castres, 프랑스, 81 000
- CHIC
-
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Bas-Rhin
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Strasbourg, Bas-Rhin, 프랑스, 67000
- Hopitaux Universitaires de Strasbourg
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Calvados
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Caen, Calvados, 프랑스, 14076
- Centre François Baclesse
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for patients:
- 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
Exclusion Criteria for patients:
- Patients under 75 years
- Patients with recurrent or metastatic
- Persons deprived of liberty or under guardianship
Inclusion Criteria for control population:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: geriatric assessment
|
A single geriatric assessment with a geriatrician was proposed to patients and to control population.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
impact of treatments
기간: 10 years after treatment for cancer prostate
|
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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Evaluate the anxiety of patients and controls
기간: 10 years after treatment for cancer prostate
|
Evaluate the anxiety of patients and controls
|
10 years after treatment for cancer prostate
|
|
Assessing depression patients and controls
기간: 10 years after treatments for cancer prostate
|
Assessing depression patients and controls
|
10 years after treatments for cancer prostate
|
|
Assess the nutritional status of patients and controls
기간: 10 years after treatments for cancer prostate
|
Assess the nutritional status of patients and controls
|
10 years after treatments for cancer prostate
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PROGE
- 2011-A01256-35 (기타 식별자: ID-RCB number)
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