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Sponsors and Collaborators: |
Queensland Centre for Gynaecological Cancer The University of Queensland Royal Brisbane and Women's Hospital Mater Adult Hospital and Mater Public Hospital Queensland Institute of Medical Research Queensland University of Technology |
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Information provided by: | Queensland Centre for Gynaecological Cancer |
ClinicalTrials.gov Identifier: | NCT00604994 |
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 and 2009.
Condition |
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Benign Gynaecological Diseases Malignant Gynaecological Diseases |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer |
Estimated Enrollment: | 1000 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Malignant gynaecological diseases
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Benign gynaecological diseases.
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Pathological swelling of the lower limbs (lymphoedema) is widely accepted to be a common consequence of treatment for gynaecological cancer. It is both a serious and debilitating complication, associated with significant morbidity, which impacts physically and emotionally on otherwise healthy women. Lymphoedema can also affect patients' ability to earn an income, especially if their work requires prolonged periods of standing or walking.
The causes of lymphoedema are largely unknown with clinical data scarce regarding its onset time and incidence after gynaecological cancer treatment.
The following hypotheses will be tested to address the aims of the project:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Hospital clinics.
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda Rogers | +61 7 3636 2144 | Linda_Rogers@health.qld.gov.au |
Contact: Monika Janda, PhD | +61 7 3138 9674 | m.janda@qut.edu.au |
Australia, Queensland | |
Royal Brisbane and Women's Hospital | Recruiting |
Herston, Queensland, Australia, 4029 | |
Contact: Andreas Obermair, MD FRANZCOG CGO +61 7 3636 8501 andreas_obermair@health.qld.gov.au | |
Contact: Linda Rogers +61 7 3636 4343 Linda_Rogers@health.qld.gov.au | |
Principal Investigator: Andreas Obermair, MD CGO | |
Sub-Investigator: Jim Nicklin, MBBS CGO | |
Sub-Investigator: Russell Land, PhD MBBS CGO | |
Mater Public Hospital | Recruiting |
South Brisbane, Queensland, Australia, 4101 | |
Contact: Lewis Perrin, MBBS CGO +61 7 3399 6862 lewisperrin@mc.mater.org.au | |
Contact: Linda Rogers +61 7 3636 4343 Linda_Rogers@health.qld.gov.au | |
Principal Investigator: Lewis Perrin, MBBS CGO | |
Sub-Investigator: Alex Crandon, MBBS CGO | |
Sub-Investigator: Marcello Nascimento |
Principal Investigator: | Andreas Obermair, MD FRANZCOG CGO | Queensland Centre for Gynaecological Cancer |
Responsible Party: | Queensland Centre for Gynaecological Cancer ( Professor Andreas Obermair ) |
Study ID Numbers: | LEGS |
Study First Received: | January 13, 2008 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00604994 |
Health Authority: | Australia: National Health and Medical Research Council |
Lymphoedema Gynaecology Oncology |
Malignant Benign Incidence |
Lymphedema Genital Diseases, Female Lymphatic Diseases |