NCT01614587

Brief Summary

The objective is to explore the genetic predisposition to early pelvic organ prolapse after adequate surgical repair by exploring the association between pelvic organ prolapse recurrences and certain polymorphisms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 9, 2017

Status Verified

June 1, 2017

Enrollment Period

3.1 years

First QC Date

May 31, 2012

Last Update Submit

June 8, 2017

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapserecurrence of pelvic organ prolapsegenetic predispositionSNP microarray analysispelvic floorgenetic factorsadequate prolapse repairpolymorphismssurgical failurereoperationDNAbuccal swabsTaqMan SNP allelic discriminiation assaysduplex real-time PCRgenome-wide SNP microarraysnext-generation sequencing

Outcome Measures

Primary Outcomes (1)

  • SNP microarray analysis from recurrent prolapse subjects and controls

    DNA will be evaluated by a variety of methods. For example, candidate polymorphisms may be evaluated using TaqMan SNP allelic discrimination assays which are based upon duplex real-time PCR. In addition, genome-wide SNP microarrays may be employed in order to perform a whole genome association study. Additional analysis such as DNA resequencing may also be required in order to identify causative polymorphisms linked to the newly associated SNPs. Other methods of DNA analysis such as next-generation sequencing may also be warranted.

    12 months post-operative, DNA will be collected

Secondary Outcomes (1)

  • Compare all peri-operative characteristics and demographics between groups

    12 months post-operative

Study Arms (2)

Cases

1. Early, unexplained recurrence (within six months of procedure) after Sacrocolpopexy 2. The recurrence required treatment (surgery or pessary)

Controls

1. Sacrocolpopexy during the same period 2. No recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women suffering from pelvic organ prolapse

You may qualify if:

  • Cases: early, unexplained recurrence (within 6 months of procedure) after sacrocolpopexy), the recurrence required treatment (surgery or pessary) Controls: sacrocolpopexy during the same period, no recurrence, no reoperation, no retreatment to date (minimum of 12 months from surgery)

You may not qualify if:

  • Obvious surgical technical failure
  • Use of other graft material than polypropylene mesh
  • Planned two staged operation
  • Contraindications to surgery based on existing medical conditions
  • Pregnancy
  • Desire for pregnancy in the future

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Related Publications (1)

  • St Louis S, Scott R, Lewis C, Salamon C, Pagnillo J, Treff N, Taylor D, Culligan P. Genetic Mutation that May Contribute to Failure of Prolapse Surgery in White Women: A Case-Control Study. J Minim Invasive Gynecol. 2016 Jul-Aug;23(5):726-30. doi: 10.1016/j.jmig.2016.02.019. Epub 2016 Mar 2.

    PMID: 26944198DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA obtained from a buccal swab

MeSH Terms

Conditions

Pelvic Organ ProlapseGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDisease SusceptibilityDisease AttributesPathologic Processes

Study Officials

  • Richard Scott, MD

    Reproductive Medicine Associates

    PRINCIPAL INVESTIGATOR

  • Patrick Culligan, MD

    Atlantic Health System

    PRINCIPAL INVESTIGATOR

  • Charbel Salamon, MD

    Atlantic Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 8, 2012

Study Start

March 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

June 9, 2017

Record last verified: 2017-06

Locations

US(1)