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Clinical Trials in France / NCT03418844
Active, not recruiting Not applicable

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

NCT03418844 · tracked via the Priya Life Science France tracker
Sponsor
Centre Francois Baclesse
Phase
Not applicable
Started
2018-05-07
Last updated
2025-09-22

Condition(s) studied

Germ Cell TumorSex Cord Stromal TumorMalignant Non-epithelial Ovarian Tumors

Investigational drug(s) / intervention(s)

Self-questionnaires of living conditions and quality of lifeCardiac, pulmonary, auditory and biological assessment

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)

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

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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 outcome measure(s)

  • 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

Trial sites (19)

FacilityCityRegionStatus
HEGP Paris Paris
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
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 France

More Centre Francois Baclesse trials in France

Collection of Endometrial Cancer-derived Organoids to Evaluate the Efficacy of PARP Inhibitors: PENDOR Pilot Study Recruiting
MEASUREMENT OF CIRCULATING MUTATION BURDEN Recruiting
Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation. Recruiting
Remotely Supervised Computerized Cognitive Stimulation to Reduce Post-chemotherapy Cognitive Difficulties in Patients Treated for Localized Breast Cancer Recruiting
Efficacy of Adapted Physical Activity on a Walking Platform in Elderly Patients HOspitalized for Cancer Surgery Recruiting

Other trials for the same condition

Morbidity, Long-term Side Effects and Quality of Life in Germ-cell Tumor Long Survivors Treated with High-dose Chemotherapy and Autologous Stem Cell Transplant Recruiting
Thromboprophylaxis in Good and Intermediate Prognosis Advanced Germ Cell Tumors Recruiting
Standard-Dose Combination Chemotherapy or High-Dose Combination Chemotherapy and Stem Cell Transplant in Treating Patients With Relapsed or Refractory Germ Cell Tumors Active, not recruiting
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03418844 on ClinicalTrials.gov ↗ ← All trials in France