NCT00604994

Brief Summary

This project will conduct a prospective, longitudinal, observational cohort study to assess the onset and incidence of lymphoedema, as well as investigate factors associated with its development among women newly diagnosed with gynaecological cancers in 2008 to 2011.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
761

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 13, 2008

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

August 20, 2013

Status Verified

August 1, 2013

Enrollment Period

4.6 years

First QC Date

January 13, 2008

Last Update Submit

August 18, 2013

Conditions

Female Genital DiseasesOvarian CancerCervical CancerEndometrial CancerVulval Cancer

Keywords

LymphoedemaGynaecologyOncologyMalignantBenignIncidence

Outcome Measures

Primary Outcomes (4)

  • Time of onset of lymphoedema after gynaecological cancer treatment.

    2 years

  • Incidence of lymphoedema after gynaecological cancer treatment.

    2 years

  • Point prevalence of lymphoedema after gynaecological cancer treatment.

    2 years

  • Severity of lymphoedema after gynaecological cancer treatment.

    2 years

Secondary Outcomes (3)

  • Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.

    2 years

  • Impact of risk factors on development of lymphoedema.

    2 years

  • Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.

    2 years

Study Arms (2)

Malignant

Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina

Benign

Patients without malignant gynaecological cancers

Eligibility Criteria

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

Women with gynaecological conditons requiring treatment

You may qualify if:

  • Patients scheduled for surgery of benign or malignant gynaecological diseases as determined jointly by the surgeon and the patient.
  • Non-pregnant female patients.
  • Over 18 years of age at time of surgery.
  • Patients who understand the conditions of the study and are willing to participate for the length of the prescribed term of follow-up.
  • Patients who are capable of, and have given, informed consent to their participation in the study.

You may not qualify if:

  • Patients with a pacemaker.
  • Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

Location

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Health Services

South Brisbane, Queensland, 4101, Australia

Location

Royal Women's Hospital

Carlton, Victoria, 3053, Australia

Location

Related Links

MeSH Terms

Conditions

Genital Diseases, FemaleOvarian NeoplasmsUterine Cervical NeoplasmsEndometrial NeoplasmsVulvar NeoplasmsLymphedemaNeoplasms

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesVulvar DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Andreas Obermair, MD FRANZCOG CGO

    Queensland Centre for Gynaecological Cancer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2008

First Posted

January 30, 2008

Study Start

June 1, 2008

Primary Completion

January 1, 2013

Study Completion

April 1, 2013

Last Updated

August 20, 2013

Record last verified: 2013-08

Locations

AU(6)