Mechanisms and Factors Responsible for the Inhibition of... | NCT02171845

Studies
Mechanisms and Factors Responsible for the Inhibition of Transposons During Fetal Gonad Development in Humans

NCT02171845

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Recruiting

Last Update Posted

Jul 8, 2022Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Medical Termination of Pregnancy
Voluntary Termination of Pregnancy

Interventions

surgical biopsies

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2014Actual

Primary Completion Date

Jan 2027Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Jun 23, 2014

First Posted Date

Jun 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2022

Last Update Posted Date

Jul 8, 2022Actual

Description Module

Brief Summary

This is a single-centre study over 36 months for the inclusion of 30 patients. The selection and inclusion of patients will take place according to the criterion of Medical Termination of Pregnancy at 4 different gestational ages (8-12 weeks of gestation (WG)), 13-16 WG, 17-23 WG and 25-35 WG. The tissue analysed will principally be the gonads, other somatic tissue will also be systematically harvested in parallel (liver and psoas muscle) for control purposes. The gonads will be subjected to molecular biology analyses destined to quantify the expression of transposons and their inhibitors.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Label	Type	Description	Intervention Names
Foetus			Other: surgical biopsies

Name	Type	Description	Arm Group Labels	Other Names
surgical biopsies	Other		Foetus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Spatio-temporal analysis of the activity of TEs by RT-qPCR and immunostaining		Baselines

Secondary Outcomes

Measure	Description	Time Frame
Promoter methylation profile by pyrosequencing		Baselines

Other Outcomes

Measure	Description	Time Frame
Spatiotemporal analysis piARN way: RT qPCR, Small RNA Seq, and immunoprecipitation of proteins PIWI		Baselines

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Couple or mother who has provided written informed consent
Foetus between 10 and 37 weeks of amenorrhea (WA)
Male foetus
Foetus obtained following medical termination of pregnancy or voluntary termination of pregnancy

Exclusion Criteria:

persons without national health insurance cover
foetus presenting aneuploidy
foetus presenting a malformation of the genital organs

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Weeks

Maximum Age

37 Weeks

Standard Ages

Child

Study Population

Male foetuses of 10 to 37 weeks of amenorrhea obtained following medical termination of pregnancy or voluntary termination of pregnancy.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patricia FAUQUE	Contact	3.80.29.50.31	+33	patricia.fauque@chu-dijon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de DIJON	Recruiting	Dijon		21079	France