Gynecologic CancerNCT02069171
Cross-sectional and Questionnaire Study for Leg Lymphedema
An observational study of Gynecologic Cancer, run by National Cancer Center, Korea.
Trial summary
The purpose of this study is to identify the incidence,feature,clinical significance for leg lymphedema after gynecologic cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- How many people
- 333 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Nov 2012
- 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: the patient who gynecologic cancer treatment at National Cancer Center (2001~2011)
Who may be able to join
- the patient who gynecologic cancer treatment at National Cancer Center , Korea(2001~2011)
- no active cancer treatment at the moment
- available telephone communication
- exclusion criteria 1. The patient unlikely to comply with the protocol
- <More information by cancer type>
- early ovarian cancer group Inclusion criteria were early stage epithelial ovarian cancer*, no active treatment, available telephone communication with patients, and ability and willingness to provide verbal informed consent.
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- early ovarian cancer (FIGO stage I and II) at National Cancer Center, Korea who underwent cytoreductive and staging surgery between January 2001 and December 2010
- locally advanced cervical cancer group patients with locally advanced cervical cancer who treatment at National Cancer Center, Korea between October 2001 and July 2007. Of 222 patients with locally advanced cervical cancer, 74 patients were underwent pretreatment laparoscopic surgical staging and 148 patients received radiotherapy . Women with locally advanced cervical cancer, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study.
- primary endometrial cancer group patients with endometrial cancer who underwent surgery, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study
Who cannot join
None listed.
About this study
Official title: The Cross-sectional and Questionnaire Study of Pelvic and Lower Extremity Lymphedema After Treatment of Gynecological Disease
The purpose of this study is to identify the incidence,feature,clinical significance for leg lymphedema after gynecologic cancer treatment.
Read the detailed description
Medical records will reviewed. And all patients who met the inclusion criteria will contacted by a telephone call by a clinical research coordinator. The telephone interview questionnaire for Lower Extremity Edema (LEE) and gynecologic cancer lymphedema questionnaire (GCLQ) will t take approximately 20-30 min to complete. The questionnaire for LEE included onset, severity, location, duration, and management. Patients will also questioned concerning deep vein thrombosis to exclude other causes of LEE. LEE is defined as subjective edema of lower extremity based on patients' complaint. LLL is defined based on a clinical diagnosis of lymphedema by a physician.
- Conditions
- Gynecologic Cancer
- Keywords
- Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymph node dissection, Gynecologic Cancer Lymphedema Questionnaire
- Medical subject headings
- Lymphedema
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 |
|---|---|---|
| early ovarian cancer group | Not described | |
| locally advanced cervical cancer group | Not described | |
| primary endometrial cancer group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gynecologic Cancer Lymphedema Questionnaire
There are no more follow up except one time telephone interview.
Measured: The study outcome measure will be assessed by telephone interview , one time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Myong Cheol Lim, National Cancer Center, Korea
- Investigators
- Myong Cheol Lim, MD,PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069171
- Sponsor's protocol ID
- NCC_GO_2012_01_2
- Other IDs
- NCCNCS-12-565
- Status last verified
- Feb 2014
- First submitted
- 31 May 2013
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cross-sectional and Questionnaire Study of Pelvic and Lower Extremity Lymphedema After Treatment of Gynecological Disease
- ClinicalTrials.gov ID
- NCT02069171
- Acronym / sponsor ID
- NCC_GO_2012_01_2
- Conditions
- Gynecologic Cancer
- Keywords
- Lower extremity edema, Lower leg lymphedema, Lower leg edema, Lymphedema, Pelvic lymph node dissection, Gynecologic Cancer Lymphedema Questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Feb 2014 (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.
The purpose of this study is to identify the incidence,feature,clinical significance for leg lymphedema after gynecologic cancer treatment.
Detailed description
Medical records will reviewed. And all patients who met the inclusion criteria will contacted by a telephone call by a clinical research coordinator. The telephone interview questionnaire for Lower Extremity Edema (LEE) and gynecologic cancer lymphedema questionnaire (GCLQ) will t take approximately 20-30 min to complete. The questionnaire for LEE included onset, severity, location, duration, and management. Patients will also questioned concerning deep vein thrombosis to exclude other causes of LEE. LEE is defined as subjective edema of lower extremity based on patients' complaint. LLL is defined based on a clinical diagnosis of lymphedema by a physician.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| early ovarian cancer group | – | – |
| locally advanced cervical cancer group | – | – |
| primary endometrial cancer group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patient who gynecologic cancer treatment at National Cancer Center (2001~2011)
Key inclusion criteria (9 listed)
- exclusion criteria 1. The patient unlikely to comply with the protocol
- <More information by cancer type>
- early ovarian cancer group Inclusion criteria were early stage epithelial ovarian cancer*, no active treatment, available telephone communication with patients, and ability and willingness to provide verbal informed consent.
- early ovarian cancer (FIGO stage I and II) at National Cancer Center, Korea who underwent cytoreductive and staging surgery between January 2001 and December 2010
- locally advanced cervical cancer group patients with locally advanced cervical cancer who treatment at National Cancer Center, Korea between October 2001 and July 2007. Of 222 patients with locally advanced cervical cancer, 74 patients were underwent pretreatment laparoscopic surgical staging and 148 patients received radiotherapy . Women with locally advanced cervical cancer, no active treatment at survey, available telephone communication, and ability and willingness to provide verbal informed consent were considered to include in the current study.
Key exclusion criteria (0 listed)
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
Gynecologic Cancer Lymphedema Questionnaire
Time frame: The study outcome measure will be assessed by telephone interview , one time.
There are no more follow up except one time telephone interview.
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 24 Feb 2014.
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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.
Myong Cheol Lim, MD,PhD principal investigator
National Cancer Center, Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer, run by National Cancer Center, Korea.
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 9 inclusion and 0 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 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Gynecologic Cancer Lymphedema Questionnaire (time frame: The study outcome measure will be assessed by telephone interview , one time.). 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 24 Feb 2014.