Gynecologic CancerNCT03515993
Follow-up in Gynecological Cancer Survivors
An observational study of Gynecologic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 9 countries.
Trial summary
A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- How many people
- 1,100 participants
- Where
- 21 sitesin 9 countries
- Study dates
- 21 Feb 2019to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Gynecologic cancer patients after primary treatment attending participating hospitals for routine follow-up.
Who may be able to join
- Histological proven gynecological cancer (cervical, endometrial, ovarian (including fallopian tube and peritoneal primary), vulva).
- FIGO stage I-IV before completion of primary therapy.
- Disease-free without any evidence of relapse: no symptoms or signs potentially indicating recurrent disease (assessed according to standard clinical parameters using physical and gynecological examination, blood tests, CA 125 (ovarian cancer), or radiological imaging techniques).
- At least 6 months but no more than 5 years since completion of primary treatment.
- Performance status 0, 1 or 2 (WHO scale).
- Age ≥ 18 years.
- Ability to understand and fill out questionnaires.
- Written informed consent according to ICH/GCP, and national/local regulations.
Who cannot join
- Other cancer diagnosis in the past 5 years.
- Patients participating in interventional clinical studies with Quality of Life as primary endpoint.
- Any psychological (including pre-existing psychiatric disorders), familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Trial locations and contacts
21 sites in 9 countries.
21 sites in 9 countries
Belgium4 sites
ZNA Middelheim
Antwerp
Universitair Ziekenhuis Gent
Ghent
Centre Hospitalier Chretien (CHC) - CHC MontLegia
Liège
ZNA Jan Palfijn
Merksem
Spain4 sites
Hospital Universitario La Paz
Madrid
Hospital Universitario San Carlos
Madrid
Complejo Hospitalario de Navarra
Pamplona
Hospital Universitario de Salamanca
Salamanca
Italy3 sites
Ospedale San Gerardo
Monza
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino
United Kingdom3 sites
Northampton General Hospital NHS Trust
Cliftonville, Northampton, NN1 5BD
NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital
Glasgow
East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita
Margate, Kent, CT9 4AN
Germany2 sites
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel
HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke
Wuppertal
Netherlands2 sites
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, NL 6525
UMC-Academisch Ziekenhuis Utrecht
Utrecht, NL 3584 CX
About this study
Official title: Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Study
A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment
Read the detailed description
The objective of this study is to identify physical and psychosocial problems and needs after treatment for gynecological cancer.
1100 patients stratified by cancer sites and treatment - a minimum of 120 patients within each stratum - will be recruited.
Institutional data on follow-up policy, demographic and clinical data (related to treatment history and tumor characteristics) will be collected. Patients will complete a set of 76 Quality of Life questions, at one single time point.
Descriptive analyses will be conducted to characterize the collected data. Multivariate model building will be used to identify patterns of physical, psychological and social problems based on factors specific to the patient and to the disease. Logistic multinomial or continuous regression analysis will be used to investigate which socio-demographic, clinical variables, or institutional are associated significantly with compromised quality of life and sexual health outcomes. Exploratory factor analysis will be used to explore the factor structure of the various PROMs to identify issue clustering.
- Conditions
- Gynecologic Cancer
- Keywords
- long-term survival, gynecologic cancer, quality of life
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
Measured: 15 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered questions on anxiety (from the EORTC quality of life item library)
Measured: 15 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
Measured: 15 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered EORTC Sexual Health Questionnaire
Measured: 15 months after first patient inclusion
Health-related quality of life
It will be evaluated using self-administered Distress Thermometer
Measured: 15 months after first patient inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start21 Feb 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515993
- Sponsor's protocol ID
- EORTC-1514-QLG-GCG
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2018
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No