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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up in Gynecological Cancer Survivors: An EORTC QLG-GCG Survivorship Study
- ClinicalTrials.gov ID
- NCT03515993
- Acronym / sponsor ID
- EORTC-1514-QLG-GCG
- Conditions
- Gynecologic Cancer
- Keywords
- long-term survival, gynecologic cancer, quality of life
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gynecologic cancer patients after primary treatment attending participating hospitals for routine follow-up.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life
Time frame: 15 months after first patient inclusion
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire
Health-related quality of life
Time frame: 15 months after first patient inclusion
It will be evaluated using self-administered questions on anxiety (from the EORTC quality of life item library)
Health-related quality of life
Time frame: 15 months after first patient inclusion
It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire
Health-related quality of life
Time frame: 15 months after first patient inclusion
It will be evaluated using self-administered EORTC Sexual Health Questionnaire
Health-related quality of life
Time frame: 15 months after first patient inclusion
It will be evaluated using self-administered Distress Thermometer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Belgium, Spain, Italy, United Kingdom, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: 15 months after first patient inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.