Clinical Trials in Germany / NCT03515993
Active, not recruiting
Observational
Follow-up in Gynecological Cancer Survivors
NCT03515993 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Gynecologic Cancer
Study summary
A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Health-related quality of life — 15 months after first patient inclusion
It will be evaluated using self-administered EORTC QLQ-C30 questionnaire - Health-related quality of life — 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 — 15 months after first patient inclusion
It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire - Health-related quality of life — 15 months after first patient inclusion
It will be evaluated using self-administered EORTC Sexual Health Questionnaire - Health-related quality of life — 15 months after first patient inclusion
It will be evaluated using self-administered Distress Thermometer
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| Medical University of Graz | Graz | Austria | |
| ZNA Middelheim | Antwerp | Belgium | |
| Universitair Ziekenhuis Gent | Ghent | Belgium | |
| Centre Hospitalier Chretien (CHC) - CHC MontLegia | Liège | Belgium | |
| ZNA Jan Palfijn | Merksem | Belgium | |
| Universitaetsklinikum Schleswig-Holstein - Campus Kiel | Kiel | Germany | |
| HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke | Wuppertal | Germany | |
| Ospedale San Gerardo | Monza | Italy | |
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" | Naples | Italy | |
| Azienda Ospedaliera Ordine Mauriziano di Torino | Torino | Italy | |
| King Hussein Cancer Center | Amman | Jordan | |
| Radboudumc - Radboud University Medical Center Nijmegen | Nijmegen | Netherlands | |
| UMC-Academisch Ziekenhuis Utrecht | Utrecht | Netherlands | |
| Medical University Of Gdansk | Gdansk | Poland | |
| Hospital Universitario La Paz | Madrid | Spain | |
| Hospital Universitario San Carlos | Madrid | Spain | |
| Complejo Hospitalario de Navarra | Pamplona | Spain | |
| Hospital Universitario de Salamanca | Salamanca | Spain | |
| East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita | Margate | Kent | |
| Northampton General Hospital NHS Trust | Cliftonville | Northampton | |
| NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital | Glasgow | United Kingdom |
More European Organisation for Research and Treatment of Cancer - EORTC trials in Germany
Other trials for the same condition
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 NCT03515993 on ClinicalTrials.gov ↗ ← All trials in Germany