Female Genital DiseasesLEGSNCT00604994
Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
An observational study of Female Genital Diseases and Ovarian Cancer, run by Queensland Centre for Gynaecological Cancer at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Genital Diseases, Ovarian Cancer, Cervical Cancer
- How many people
- 761 participants
- Where
- 6 sitesAustralia
- Study dates
- Jun 2008to Apr 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Women with gynaecological conditons requiring treatment
Who may be able to join
- 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.
Who cannot join
- Patients with a pacemaker.
- Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
The Wesley Hospital
Auchenflower, Queensland, 4066
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Royal Women's Hospital
Carlton, Victoria, 3053
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Mater Health Services
South Brisbane, Queensland, 4101
About this study
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.
Read the detailed description
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:
- At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
- Patient's age, as well as their body mass index (BMI), area of residence, degree of physical exercise, type of disease (uterine, cervical, ovarian, vulval/vaginal cancer; benign disease), mode of treatment (extent of lymph node dissection, radiotherapy, chemoradiation) and delay in wound healing are independent risk factors for lower-limb lymphoedema.
- Patients who develop lymphoedema after gynaecological cancer treatment, will experience increased pain, lower quality of life (including worse body-image), and decreased sexual \& financial well-being, compared to those who do not develop lymphoedema.
- There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.
- Conditions
- Female Genital Diseases, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Vulval Cancer
- Keywords
- Lymphoedema, Gynaecology, Oncology, Malignant, Benign, Incidence
- Medical subject headings
- Genital Diseases, Female, Ovarian Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Vulvar Neoplasms, Lymphedema, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Malignant | Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina | |
| Benign | Patients without malignant gynaecological cancers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of onset of lymphoedema after gynaecological cancer treatment.
Measured: 2 years
Incidence of lymphoedema after gynaecological cancer treatment.
Measured: 2 years
Point prevalence of lymphoedema after gynaecological cancer treatment.
Measured: 2 years
Severity of lymphoedema after gynaecological cancer treatment.
Measured: 2 years
Secondary outcomes (3)
Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.
Measured: 2 years
Impact of risk factors on development of lymphoedema.
Measured: 2 years
Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Genital DiseasesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queensland Centre for Gynaecological Cancer
- Sponsor type
- Other government
- Collaborators
- The University of Queensland, Royal Brisbane and Women's Hospital, Mater, Mater Private Hospital, Queensland Institute of Medical Research, Queensland University of Technology, Australia New Zealand Gynaecological Oncology Group, Cancer Australia
- Responsible party
- Sponsor
- Investigators
- Andreas Obermair, MD FRANZCOG CGO, Principal investigator, Queensland Centre for Gynaecological Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00604994
- Sponsor's protocol ID
- LEGS
- Acronym
- LEGS
- Status last verified
- Aug 2013
- First submitted
- 13 Jan 2008
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Lymphoedema Among Patients With Gynaecological Cancer
- ClinicalTrials.gov ID
- NCT00604994
- Acronym / sponsor ID
- LEGS / LEGS
- Conditions
- Female Genital Diseases, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Vulval Cancer
- Keywords
- Lymphoedema, Gynaecology, Oncology, Malignant, Benign, Incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 761 participants (actual)
- Lead sponsor
- Queensland Centre for Gynaecological CancerOther government
- Collaborators
- The University of Queensland, Royal Brisbane and Women's Hospital, Mater, Mater Private Hospital, Queensland Institute of Medical Research, Queensland University of Technology, Australia New Zealand Gynaecological Oncology Group, Cancer Australia
- Study start
- Jun 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Jan 2008 (estimated)
- 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.
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.
Detailed description
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:
- At least 20% of patients will develop lower-limb lymphoedema following gynaecological cancer treatment.
- Patient's age, as well as their body mass index (BMI), area of residence, degree of physical exercise, type of disease (uterine, cervical, ovarian, vulval/vaginal cancer; benign disease), mode of treatment (extent of lymph node dissection, radiotherapy, chemoradiation) and delay in wound healing are independent risk factors for lower-limb lymphoedema.
- Patients who develop lymphoedema after gynaecological cancer treatment, will experience increased pain, lower quality of life (including worse body-image), and decreased sexual \& financial well-being, compared to those who do not develop lymphoedema.
- There will be at least 10% difference in the incidence of lower-limb lymphoedema between patients treated for gynaecological cancer compared to benign diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malignant | – | –Patients with malignant gynaecological conditions including cancers of the cervix, uterus, ovary, vulva and vagina |
| Benign | – | –Patients without malignant gynaecological cancers |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with gynaecological conditons requiring treatment
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with a pacemaker.
- Allergies against adhesive electrodes and extensive internal metal plates are ineligible for BIS measurement.
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
Time of onset of lymphoedema after gynaecological cancer treatment.
Time frame: 2 years
Incidence of lymphoedema after gynaecological cancer treatment.
Time frame: 2 years
Point prevalence of lymphoedema after gynaecological cancer treatment.
Time frame: 2 years
Severity of lymphoedema after gynaecological cancer treatment.
Time frame: 2 years
3 secondary outcomes
Prevalence of key risk factors of post-treatment lymphoedema among patients with gynaecological cancer.
Time frame: 2 years
Impact of risk factors on development of lymphoedema.
Time frame: 2 years
Lymphoedema development in patients treated for gynaecological cancer compared to patients with benign disease.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
- QCGC ResearchLink provided by the sponsor.
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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.
Andreas Obermair, MD FRANZCOG CGO principal investigator
Queensland Centre for Gynaecological Cancer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Genital Diseases and Ovarian Cancer, run by Queensland Centre for Gynaecological Cancer at 6 sites in Australia.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time of onset of lymphoedema after gynaecological cancer treatment. (time frame: 2 years). The study lists 4 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 20 Aug 2013.