Clinical trial NCT03418844: Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
Official title: Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Germ Cell Tumor
Sex Cord Stromal Tumor
Malignant Non-epithelial Ovarian Tumors
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: ARCAGY/ GINECO GROUP
First posted: 2018-02-01
Enrollment: 268
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients and healthy volunteers will complete several self-questionnaires on living conditions and quality of life. Patients will also perform a cardiac, pulmonary, auditory and biological assessment
Primary purpose: OTHER

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: The chronic fatigue by questionnaires
timeFrame: 2 years after surgery
measure: 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.
timeFrame: 2 years after surgery
measure: The quality of life by questionnaires
timeFrame: 2 years after surgery
Secondary outcomes:
measure: The fertility monitoring by questionnaires
timeFrame: 2 years after surgery
measure: The symptoms of menopause by questionnaires
timeFrame: 2 years after surgery
measure: Theimpact of cancer and its treatments on the trajectory and professional situation by questionnaires(access to work, professional ambition, financial situation ...);
timeFrame: 2 years after surgery
measure: The parental projects by age (≤ 45 years) by questionnaires
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Paul Papin
city: Besançon
country: France
facility: CHU Besançon Jean MINJOZ
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bourg-en-Bresse
country: France
facility: CH Fleyriat
city: Caen
country: France
facility: Centre François Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Lyon
country: France
facility: Centre Léon Berard
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Nantes
country: France
facility: Institut de Cancérologie de l'Ouest
city: Paris
country: France
facility: GH Cochin Broca Hôtel-Dieu
city: Paris
country: France
facility: HEGP
city: Paris
country: France
facility: Hôpital Diaconesses-Croix St Simon
city: Paris
country: France
facility: Institut Curie,
city: Paris
country: France
facility: Institut Gustave Roussy
city: Poitiers
country: France
facility: CHU Poitiers
city: Reims
country: France
facility: Institut Jean Godinot
city: Rennes
country: France
facility: Institut Rennais de Cancérologie
city: Strasbourg
country: France
facility: CHRU Stasbourg Hôpital Civil
Study officials:
affiliation: Centre François Baclesse
name: Florence JOLY
role: PRINCIPAL_INVESTIGATOR
References: