Lower Extremity LymphedemaNCT01914276
Lymphedema in Endometrial Cancer
An observational study of Lower Extremity Lymphedema and Endometrial Cancer, run by Duke University at 1 site in United States.
Trial summary
Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lower Extremity Lymphedema, Endometrial Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2017
- 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: (1) women older than 18 years old, (2) endometrial cancer, (3) suitable candidates for surgery, (4) scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC), (5) no severe physical or mental comorbidity
Who may be able to join
- women older than 18 years old,
- endometrial cancer,
- suitable candidates for surgery,
- scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC),
- no severe physical or mental comorbidity
Who cannot join
- metastatic disease,
- laparotomy
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery
Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery.
Data analysis and risk/safety issues: The proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.
- Conditions
- Lower Extremity Lymphedema, Endometrial Cancer
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
change in incidence of lower-extremity lymphedema
Measured: 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer
Secondary outcomes (1)
change in lymphedema-related morbidity
Measured: 1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity LymphedemaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Havrilesky, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914276
- Sponsor's protocol ID
- Pro00047483
- Status last verified
- Jun 2017
- First submitted
- 31 Jul 2013
- Last updated
- 23 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Postoperative Lower-extremity Lymphedema and Quality of Life Among Women Undergoing Endometrial Cancer Staging Surgery
- ClinicalTrials.gov ID
- NCT01914276
- Acronym / sponsor ID
- Pro00047483
- Conditions
- Lower Extremity Lymphedema, Endometrial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2017 (actual)
- First posted
- 2 Aug 2013 (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.
Objectives: (1) To determine the incidence of lower-extremity lymphedema after staging surgery for endometrial cancer; (2) to describe lymphedema-related morbidity after staging surgery for endometrial cancer and (3) to evaluate pre- and post-operative quality of life in women with endometrial cancer who undergo staging surgery.
Data analysis and risk/safety issues: The proposed study will consist of a convenience sample of women who undergo minimally invasive surgery for endometrial cancer over a 1 year period. The investigators anticipate enrollment of 75 to 100 women. Frequency tables and difference with its 95% exact confidence intervals between pre-and post-operative lower extremity lymphedema measurements and quality of life questionnaires will be estimated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (1) women older than 18 years old, (2) endometrial cancer, (3) suitable candidates for surgery, (4) scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC), (5) no severe physical or mental comorbidity
Key inclusion criteria (5 listed)
- women older than 18 years old,
- endometrial cancer,
- suitable candidates for surgery,
- scheduled to undergo laparoscopy or robotic-assisted (RA) laparoscopy for endometrial cancer at Duke University Medical Center (DUMC),
- no severe physical or mental comorbidity
Key exclusion criteria (2 listed)
- metastatic disease,
- laparotomy
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
change in incidence of lower-extremity lymphedema
Time frame: 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer
1 secondary outcome
change in lymphedema-related morbidity
Time frame: 1 month 6-9 months and 12-18 months after staging surgery for endometrial cancer
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 23 Jun 2017.
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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.
Laura Havrilesky, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Extremity Lymphedema and Endometrial Cancer, run by Duke University at 1 site in United States.
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 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
change in incidence of lower-extremity lymphedema (time frame: 1 month, 6-9 months and 12-18 months after staging surgery for endometrial cancer). 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 23 Jun 2017.