Study of the Genetic and Epigenetic Causes of Recurrent Hydatidiform Moles

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2010 by Baylor College of Medicine
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01008501
First received: November 4, 2009
Last updated: December 21, 2010
Last verified: December 2010
  Purpose

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.


Condition
Hydatidiform Moles

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Genetic Studies in Gestational Trophoblastic Disease

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Biospecimen Retention:   Samples With DNA

lymphoblast DNA; tissue


Estimated Enrollment: 100
Study Start Date: December 1998
Estimated Study Completion Date: January 2018
Groups/Cohorts
A.
Individuals with recurrent or sporadic hydatidiform moles and their first-degree family members. Sometimes additional family members are also enrolled.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Individuals who have had sporadic or recurrent hydatidiform moles and their first degree relatives. Sometimes additional family members are also enrolled.

Criteria

Inclusion Criteria:

  • Personal or family history of recurrent moles or a sporadic mole
  • Presence of a mutation in NLRP7
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008501

Contacts
Contact: Ivonne Curiel 713-873-3674 icuriel@bcm.edu
Contact: Ignatia B Van den Veyver, MD 713-798-4914 iveyver@bcm.edu

Locations
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Ignatia B Van den Veyver, MD    713-798-4914    iveyver@bcm.edu   
Contact: Ivonne Curiel    713-873-3674    icuriel@bcm.edu   
Principal Investigator: Ignatia B Van den Veyver, MD         
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Ignatia B Van den Veyver, MD Baylor College of Medicine
  More Information

Publications:

Responsible Party: Ignatia B. Van den Veyver, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01008501     History of Changes
Other Study ID Numbers: BCM Hydatidiform Mole H7345
Study First Received: November 4, 2009
Last Updated: December 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
hydatidiform moles
complete hydatidiform moles
partial hydatidiform moles
Molar pregnancy
NLRP7
pregnancy wastage
imprinting
sporadic hydatidiform moles
recurrent hydatidiform moles

Additional relevant MeSH terms:
Gestational Trophoblastic Disease
Hydatidiform Mole
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Pregnancy Complications
Pregnancy Complications, Neoplastic
Trophoblastic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014