NCT03515993

Brief Summary

A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
9 countries

21 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Feb 2019Aug 2026

First Submitted

Initial submission to the registry

March 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

February 21, 2019

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

7.5 years

First QC Date

March 30, 2018

Last Update Submit

May 7, 2026

Conditions

Gynecologic Cancer

Keywords

long-term survivalgynecologic cancerquality of life

Outcome Measures

Primary Outcomes (5)

  • Health-related quality of life

    It will be evaluated using self-administered EORTC QLQ-C30 questionnaire

    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)

    15 months after first patient inclusion

  • Health-related quality of life

    It will be evaluated using self-administered EORTC OUT-PATSAT-C7 questionnaire

    15 months after first patient inclusion

  • Health-related quality of life

    It will be evaluated using self-administered EORTC Sexual Health Questionnaire

    15 months after first patient inclusion

  • Health-related quality of life

    It will be evaluated using self-administered Distress Thermometer

    15 months after first patient inclusion

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Gynecologic cancer patients after primary treatment attending participating hospitals for routine follow-up.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Medical University of Graz

Graz, 8036, Austria

Location

ZNA Middelheim

Antwerp, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

Centre Hospitalier Chretien (CHC) - CHC MontLegia

Liège, Belgium

Location

ZNA Jan Palfijn

Merksem, Belgium

Location

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Germany

Location

HELIOS Kliniken - Helios Klinikum Wuppertal - Klin. Univ. Witten / Herdecke

Wuppertal, Germany

Location

Ospedale San Gerardo

Monza, Italy

Location

Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

Naples, Italy

Location

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, Italy

Location

King Hussein Cancer Center

Amman, 11941, Jordan

Location

Radboudumc - Radboud University Medical Center Nijmegen

Nijmegen, NL 6525, Netherlands

Location

UMC-Academisch Ziekenhuis Utrecht

Utrecht, NL 3584 CX, Netherlands

Location

Medical University Of Gdansk

Gdansk, PL 80 211, Poland

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario San Carlos

Madrid, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

East Kent Hospitals University NHS Foundation Trust - Queen Elizabeth The Queen Mother Hospita

Margate, Kent, CT9 4AN, United Kingdom

Location

Northampton General Hospital NHS Trust

Cliftonville, Northampton, NN1 5BD, United Kingdom

Location

NHS Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre - Gartnavel General Hospital

Glasgow, United Kingdom

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2018

First Posted

May 4, 2018

Study Start

February 21, 2019

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations

GB(3)AU(1)NL(2)JO(1)ES(4)IT(3)PL(1)BE(4)DE(2)