NCT03338985

Brief Summary

Several molecular studies showed chromosomal alterations in patients with endometrial cancer, with gains in 1q, 19p, 19q, 8q, 10q and 10p and loss of 4q, 16q and 18q. Several genes of interest have been identified (P53, PTEN, PIK3CA, ß-catenin, K-ras ...). A study has already been carried out at the Reims University Hospital with inclusion of patients with endometrial cancer and patients with endometrial hyperplasia. It identified specific alterations of nosologic continuum of pathology and characterize areas of interest on the genome.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 16, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
Last Updated

January 5, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

November 8, 2017

Last Update Submit

January 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Genetic imbalances

    Genetic aberrations detected by comparative genomic hybridization (CGH arry)

    Day 0

Study Arms (1)

Group "cases patients"

EXPERIMENTAL

patients with endometrial hyperplasia or endometrial cancers

Genetic: Genetic analysis

Interventions

Genetic analysis of the samples taken during the surgery (hysterectomy or curettage resection) using CGH array technique.

Group "cases patients"

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient with endometrial hyperplasia or endometrial cancer
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program
  • patient older than 18 years

You may not qualify if:

  • \- patient with neoadjuvant chemotherapy or radiotherapy prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Damien JOLLY

Reims, France

RECRUITING

MeSH Terms

Conditions

Endometrial HyperplasiaEndometrial Neoplasms

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Central Study Contacts

Emilie RAIMOND

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 9, 2017

Study Start

October 16, 2017

Primary Completion

October 16, 2019

Study Completion

April 16, 2020

Last Updated

January 5, 2018

Record last verified: 2018-01

Locations