Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy

NCT03418844 | Active Not Recruiting

• 1 other identifier: VIVROVAIRE TR
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 19

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

Conditions

Germ Cell Tumor; Sex Cord Stromal Tumor; Malignant Non-epithelial Ovarian Tumors

Outcome Measures

Primary Outcomes (3)

• The chronic fatigue by questionnaires

  2 years after surgery

• 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

• The quality of life by questionnaires

  2 years after surgery

Secondary Outcomes (4)

• The fertility monitoring by questionnaires

  2 years after surgery

• The symptoms of menopause by questionnaires

  2 years after surgery

• 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

• The parental projects by age (≤ 45 years) by questionnaires

  2 years after surgery

Study Arms (3)

Interest group (patients treated with chemotherapy)

OTHER

Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment

Other: Self-questionnaires of living conditions and quality of life; Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment

Patient control group (patients not treated with chemotherapy)

OTHER

Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment

Other: Self-questionnaires of living conditions and quality of life; Diagnostic Test: Cardiac, pulmonary, auditory and biological assessment

Healthy volunteers

OTHER

Healthy volunteers will complete several self-questionnaires on living conditions and quality of life.

Other: Self-questionnaires of living conditions and quality of life

Interventions

Self-questionnaires of living conditions and quality of life OTHER

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)

Healthy volunteers; Interest group (patients treated with chemotherapy); Patient control group (patients not treated with chemotherapy)

Cardiac, pulmonary, auditory and biological assessment DIAGNOSTIC_TEST

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

Interest group (patients treated with chemotherapy); Patient control group (patients not treated with chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• ARCAGY/ GINECO GROUP: collaborator

Study Sites (19)

HEGP

Paris, Paris, France

Location

Centre Paul Papin

Angers, France

Location

CHU Besançon Jean MINJOZ

Besançon, France

Location

Institut Bergonié

Bordeaux, France

Location

CH Fleyriat

Bourg-en-Bresse, France

Location

Centre François Baclesse

Caen, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Centre Léon Berard

Lyon, France

Location

Institut Paoli Calmettes

Marseille, France

Location

Centre Catherine de Sienne

Nantes, France

Location

Institut de Cancérologie de l'Ouest

Nantes, France

Location

GH Cochin Broca Hôtel-Dieu

Paris, France

Location

Hôpital Diaconesses-Croix St Simon

Paris, France

Location

Institut Curie,

Paris, France

Location

Institut Gustave Roussy

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

Institut Jean Godinot

Reims, France

Location

Institut Rennais de Cancérologie

Rennes, France

Location

CHRU Stasbourg Hôpital Civil

Strasbourg, France

Location

Related Publications (1)

• Dubot C, Ray-Coquard I, Lequesne J, Pautier P, Renaud T, Selle F, Berton-Rigaud D, Frank S, De La Motte Rouge T, Kalbacher E, Provansal M, Blonz C, Orfeuvre H, Alexandre J, Augereau P, Nadeau C, Kurtz JE, Hanvic B, Fresneau B, Ahmed-Lecheheb D, Christy F, Grellard JM, Clarisse B, Gernier F, Joly F. Long-term quality of life in non-epithelial ovarian cancer survivors: TMRG-GINECO-Vivrovaire rare tumors case-control study. BMC Med. 2025 Dec 12. doi: 10.1186/s12916-025-04540-x. Online ahead of print.

  PMID: 41382138 DERIVED

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal; Sex Cord-Gonadal Stromal Tumors

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Neoplasms, Gonadal Tissue

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Florence JOLY

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 1, 2018
• Study Start: May 7, 2018
• Primary Completion: July 13, 2021
• Study Completion: December 1, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (19)