Ectopic PregnancyNCT00194168
Ectopic Pregnancy Biomarkers
An observational study of Ectopic Pregnancy, run by University of Pennsylvania at 3 sites in United States.
Trial summary
In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will investigate the presence of specific molecular markers of ectopic pregnancy. The quantification of these (and other proteins) will be performed using the Ciphergen Protein Chip system where serum is sampled with a high-throughput… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ectopic Pregnancy
- How many people
- 1,306 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2000to Nov 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women undergoing treatment for infertility at the University of Pennsylvania Penn Fertility Practice
Who may be able to join
- Reproductive-aged women
- Currently pregnant based on serum human chorionic gonadotropin level
- Present for care for pregnancy due to vaginal bleeding and/or pelvic cramping
- Final diagnosis of one of the following:
- Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
- Diagnosed ectopic pregnancy
- Ultrasound confirmation of a nonviable gestation (less 14 weeks) such as an anembryonic gestation or a fetal demise
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Southern California Women's and Children's Hospital
Los Angeles, California, 90033
University of Miami
Miami, Florida, 33101
University of Pennsylvania Reproductive Research Unit
Philadelphia, Pennsylvania, 19104
About this study
Official title: Serum Bank for Assessment of Markers of Ectopic Pregnancy
In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will investigate the presence of specific molecular markers of ectopic pregnancy. The quantification of these (and other proteins) will be performed using the Ciphergen Protein Chip system where serum is sampled with a high-throughput system. The patterns of these peaks will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. Later goals of the research will be to identify the actual proteins that correspond to the peaks which discriminate between the two clinical entitles. The goal is to identify a unique protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of an ectopic implanted gestation.
- Conditions
- Ectopic Pregnancy
- Keywords
- ectopic pregnancy
- Medical subject headings
- Pregnancy, Ectopic
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 startJun 2000
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ectopic PregnancyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,306 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Kurt T Barnhart, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194168
- Sponsor's protocol ID
- 705016
- Other IDs
- RRU002
- Status last verified
- Aug 2016
- First submitted
- 13 Sep 2005
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Barnhart KT, Guo W, Cary MS, Morse CB, Chung K, Takacs P, Senapati S, Sammel MD. Differences in Serum Human Chorionic Gonadotropin Rise in Early Pregnancy by Race and Value at Presentation. Obstet Gynecol. 2016 Sep;128(3):504-511. doi: 10.1097/AOG.0000000000001568.
PubMed 27500326Rausch ME, Sammel MD, Takacs P, Chung K, Shaunik A, Barnhart KT. Development of a multiple marker test for ectopic pregnancy. Obstet Gynecol. 2011 Mar;117(3):573-582. doi: 10.1097/AOG.0b013e31820b3c61.
PubMed 21343760
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 Bank for Assessment of Markers of Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT00194168
- Acronym / sponsor ID
- 705016
- Conditions
- Ectopic Pregnancy
- Keywords
- ectopic pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,306 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, National Institutes of Health (NIH)
- Study start
- Jun 2000
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (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.
In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will investigate the presence of specific molecular markers of ectopic pregnancy. The quantification of these (and other proteins) will be performed using the Ciphergen Protein Chip system where serum is sampled with a high-throughput system. The patterns of these peaks will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. Later goals of the research will be to identify the actual proteins that correspond to the peaks which discriminate between the two clinical entitles. The goal is to identify a unique protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of an ectopic implanted gestation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women undergoing treatment for infertility at the University of Pennsylvania Penn Fertility Practice
Key inclusion criteria (7 listed)
- Reproductive-aged women
- Currently pregnant based on serum human chorionic gonadotropin level
- Present for care for pregnancy due to vaginal bleeding and/or pelvic cramping
- Final diagnosis of one of the following:
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.
- Derived from this study: PubMed 27500326Barnhart KT, Guo W, Cary MS, Morse CB, Chung K, Takacs P, Senapati S, Sammel MD. Differences in Serum Human Chorionic Gonadotropin Rise in Early Pregnancy by Race and Value at Presentation. Obstet Gynecol. 2016 Sep;128(3):504-511. doi: 10.1097/AOG.0000000000001568.
- Derived from this study: PubMed 21343760Rausch ME, Sammel MD, Takacs P, Chung K, Shaunik A, Barnhart KT. Development of a multiple marker test for ectopic pregnancy. Obstet Gynecol. 2011 Mar;117(3):573-582. doi: 10.1097/AOG.0b013e31820b3c61.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ectopic Pregnancy, run by University of Pennsylvania at 3 sites 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 7 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 3 sites 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?
On the ClinicalTrials.gov record for NCT00194168, which also lists 2 linked publications.
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.