Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy
NCT ID: NCT03418844
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
268 participants
INTERVENTIONAL
2018-05-07
2025-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Interest group (patients treated with chemotherapy)
Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, 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
Patient control group (patients not treated with chemotherapy)
Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, 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
Healthy volunteers
Healthy volunteers will complete several self-questionnaires on living conditions and quality of life.
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)
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
Yes
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Centre Francois Baclesse
OTHER
Responsible Party
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Principal Investigators
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Florence JOLY
Role: PRINCIPAL_INVESTIGATOR
Centre François Baclesse
Locations
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HEGP
Paris, Paris, 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
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
Countries
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Other Identifiers
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VIVROVAIRE TR
Identifier Type: -
Identifier Source: org_study_id
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