- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
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Albi, Frankrig, 81000
- Clinique Claude Bernard
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Besancon, Frankrig, 25000
- CHRU
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Castres, Frankrig, 81 000
- CHIC
-
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Bas-Rhin
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Strasbourg, Bas-Rhin, Frankrig, 67000
- Hopitaux Universitaires de Strasbourg
-
-
Calvados
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Caen, Calvados, Frankrig, 14076
- Centre Francois Baclesse
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: geriatric assessment
|
A single geriatric assessment with a geriatrician was proposed to patients and to control population.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
impact of treatments
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Evaluate the anxiety of patients and controls
Tidsramme: 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
Tidsramme: 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
Tidsramme: 10 years after treatments for cancer prostate
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Assess the nutritional status of patients and controls
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10 years after treatments for cancer prostate
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PROGE
- 2011-A01256-35 (Anden identifikator: ID-RCB number)
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