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NCT01008501 · ClinicalTrials.gov registry record
Study of the Genetic and Epigenetic Causes of Recurrent Hydatidiform Moles
A clinical trial of Hydatidiform Moles, sponsored by Baylor College of Medicine.
- Active
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT01008501: Active study of Hydatidiform Moles, sponsored by Baylor College of Medicine.
NCT01008501 is a study of Hydatidiform Moles that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 100 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01008501, a study of Hydatidiform Moles, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
The researchers' laboratory is studying a rare class of highly recurrent hydatidiform moles. These are usually complete hydatidiform moles (CHM), but sometimes they are partial hydatidiform moles PHM). With sporadic moles, the difference between CHMs and PHMs is that with CHMS, there is not typically an embryo or fetus at the time of diagnosis but with a PHM there may be a fetus. Also, CHMs have 46 chromosomes in each cell. While this is the number of chromosomes that should be found, the problem is that all the chromosomes come from the father. Normally, half the chromosomes should come from the mother and half should come from the father. Unlike CHMs, PHMs have 69 chromosomes. This means that PHMs have three copies of each chromosome when they should only have two. The extra copy comes from the father. The researchers' study focuses on moles that are genetically different from these sporadic moles in that they have 23 chromosomes from the mother and 23 chromosomes from the father - just like a normally developing pregnancy. These are called biparental moles because the mutation that causes the mole comes from both parents. This mutation occurs in a gene called NLRP7. The researchers' team is working to understand how mutations in NLRP7 leads to CHMs and how these mutations may lead to other types of pregnancy loss. The researchers are also trying to discover other genetic and epigenetic factors that may lead to moles.
Primary Outcome
The researchers will isolate genetic material from blood of women with recurrent hydatidiform molar (RHM) pregnancies, their RHM pregnancies, and for some first-degree relatives. DNA sequencing along with bioinformatic analysis will be used to find changes in the genetic code unique to individuals with RHM. When a new gene is found that shows variants that are deleterious to its function in at least 3 unrelated women with RHM, but not in healthy pregnant women, the outcome (finding a new genetic
Conditions Studied
Study Locations (1)
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2000-11-07 |
| Est. Completion | 2030-01 |
What the registry record for NCT01008501 still lists
NCT01008501 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Hydatidiform Moles appearing as the primary indexed condition, and to 0 interventions.
NCT01008501 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01008501 about?
NCT01008501 is a clinical study titled "Study of the Genetic and Epigenetic Causes of Recurrent Hydatidiform Moles". The researchers' laboratory is studying a rare class of highly recurrent hydatidiform moles. These are usually complete hydatidiform moles (CHM), but sometimes they are partial hydatidiform moles PHM). With sporadic moles, the difference between CHMs and PHMs is that with CHMS, there is not typicall...
What is the current status of trial NCT01008501?
This trial is currently active not recruiting. The enrollment target is 100 participants. The study started on 2000-11-07. Estimated completion is 2030-01.
What conditions does trial NCT01008501 study?
This clinical trial studies the following conditions: Hydatidiform Moles.
Who is sponsoring clinical trial NCT01008501?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01008501 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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