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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03418844
Other study ID # VIVROVAIRE TR
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 7, 2018
Est. completion date December 2024

Study information

Verified date July 2023
Source Centre Francois Baclesse
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

While they are documented in patients in remission of testicular cancer, the sequelae of chemotherapy and the impact of the disease and its treatments on the living conditions and QoL of women in remission of rare ovarian cancer remain poorly explored. The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 268
Est. completion date December 2024
Est. primary completion date July 13, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age> 18 years; - Patient with an ovarian malignant germ cell tumor (TGMO) or a stroma tumor and / or sex cords (TSCS) treated optimally; - Patient who has had surgery and chemotherapy (interest group) or only a surgery (control group); - Patient in remission more than 2 years after the end of the initial treatment; - Relapse authorized if remission more than 2 years after the end of the treatment; - Patient with no other cancers (with the exception of basal cell skin carcinomas, in situ cancers of the breast and cervix); - Patient having signed his consent to participate Exclusion Criteria: - Pregnant or breastfeeding woman; - Psychiatric pathology that may disrupt the course of the study or prevent the interpretation of results; - Person deprived of liberty; - Major subject to a legal protection measure or unable to express his consent.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Self-questionnaires of living conditions and quality of life
Patients will complete self-questionnaires of living conditions and quality of life (MFI-20, FACT-G/FACT-O, FACT/COG-NTX, FACT-Cog, HADS, Insomnia Severity Index , International Physical Activity Questionnaire)
Diagnostic Test:
Cardiac, pulmonary, auditory and biological assessment
Patients will perform : Cardiac assesments (ECG, Carotid and humeral Doppler ultrasound, Trans-thoracic echocardiography 2D and 3D) Pulmonary and auditory assesment ( Respiratory Functional Exploration, Tonal audiogram) Blood tests

Locations

Country Name City State
France Centre Paul Papin Angers
France CHU Besançon Jean MINJOZ Besançon
France Institut Bergonié Bordeaux
France CH Fleyriat Bourg-en-Bresse
France Centre François Baclesse Caen
France Centre Jean Perrin Clermont-Ferrand
France Centre Léon Berard Lyon
France Institut Paoli Calmettes Marseille
France Centre Catherine de Sienne Nantes
France Institut de Cancérologie de l'Ouest Nantes
France GH Cochin Broca Hôtel-Dieu Paris
France HEGP Paris
France Hôpital Diaconesses-Croix St Simon Paris
France Institut Curie, Paris
France Institut Gustave Roussy Paris
France CHU Poitiers Poitiers
France Institut Jean Godinot Reims
France Institut Rennais de Cancérologie Rennes
France CHRU Stasbourg Hôpital Civil Strasbourg

Sponsors (2)

Lead Sponsor Collaborator
Centre Francois Baclesse ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The chronic fatigue by questionnaires 2 years after surgery
Primary The late sequelae of chemotherapy, particularly cardiovascular and pulmonary disorders, in adult patients in remission of a rare cancer of the ovary treated by surgery, supplemented or not by chemotherapy. 2 years after surgery
Primary The quality of life by questionnaires 2 years after surgery
Secondary The fertility monitoring by questionnaires 2 years after surgery
Secondary The symptoms of menopause by questionnaires 2 years after surgery
Secondary Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...); 2 years after surgery
Secondary The parental projects by age (= 45 years) by questionnaires 2 years after surgery
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