EndometriosisNCT00194233
Serum and Peritoneal Fluid Bank for Endometriosis Markers
An observational study of Endometriosis, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to investigate differences in protein expression profiles of blood and peritoneal fluid samples obtained from patients who do, and those who do not, have endometriosis seen during laparoscopic surgery. These profiles may include both known and novel markers for diagnosing endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jun 2008
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing Laparoscopy at HUP
Who may be able to join
- Undergoing laparoscopic surgery for one of the following indications:
- infertility
- pain
- tubal sterilization
- For cases, visualization of endometriosis
- For controls, absence of endometriosis
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: Serum and Peritoneal Fluid Bank for Assessment of Markers of Endometriosis
The purpose of this study is to investigate differences in protein expression profiles of blood and peritoneal fluid samples obtained from patients who do, and those who do not, have endometriosis seen during laparoscopic surgery. These profiles may include both known and novel markers for diagnosing endometriosis.
- Conditions
- Endometriosis
- Keywords
- Endometriosis
- Medical subject headings
- Endometriosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2003
- Primary completionJan 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Investigators
- Kurt T Barnhart, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194233
- Sponsor's protocol ID
- 708870
- Other IDs
- RRU008
- Status last verified
- Aug 2016
- First submitted
- 13 Sep 2005
- Last updated
- 16 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum and Peritoneal Fluid Bank for Assessment of Markers of Endometriosis
- ClinicalTrials.gov ID
- NCT00194233
- Acronym / sponsor ID
- 708870
- Conditions
- Endometriosis
- Keywords
- Endometriosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2003
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Sep 2005 (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 investigate differences in protein expression profiles of blood and peritoneal fluid samples obtained from patients who do, and those who do not, have endometriosis seen during laparoscopic surgery. These profiles may include both known and novel markers for diagnosing endometriosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing Laparoscopy at HUP
Key inclusion criteria (6 listed)
- Undergoing laparoscopic surgery for one of the following indications:
- For cases, visualization of endometriosis
- For controls, absence of endometriosis
Key exclusion criteria (1 listed)
- None
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
Not reported in the source record.
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 16 Aug 2016.
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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.
Kurt T Barnhart, MD, MSCE principal investigator
University of Pennsylvania
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 Endometriosis, run by University of Pennsylvania 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 6 inclusion and 1 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 16 Aug 2016. 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.
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 16 Aug 2016.