Postoperative Follow-up of Asymptomatic Papillary Microca... | NCT05873361

Studies
Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival

NCT05873361

Sponsor

University Hospital, Toulouse

Status

Active, not recruiting

Last Update Posted

Jun 22, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Papillary Carcinoma

Interventions

Questionnaire

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

ID	Type	Description	Link
2023-A00294-41	Other Identifier	ANSM

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2023Actual

Primary Completion Date

May 15, 2027Estimated

Completion Date

May 15, 2027Estimated

First Submitted Date

May 15, 2023

First Submission Date that Met QC Criteria

May 15, 2023

First Posted Date

May 24, 2023Actual

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

Jun 19, 2023

Last Update Posted Date

Jun 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a study assessing the interest of post-operative follow-up of asymptomatic papillary microcarcinomas. Today, this post-operative follow-up represents an economic cost and is a source of anxiety for patients.

The aim of this study is to determine the global survival of patients with asymptomatic papillary microcarcinoma to assess the interest of a post-operative ultrasound and/or biological follow-up.

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

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adult patients with a papillary microcarcinoma asymptomatic		Adult patients who have had a papillary microcarcinoma asymptomatic and who are followed.	Other: Questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	The questionnaire is about hypocalcemia, dysphonia and anxiety. It will be carried out by phone call for 10 minutes	Adult patients with a papillary microcarcinoma asymptomatic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	Review of medical record	10 years

Secondary Outcomes

Measure	Description	Time Frame
Disease control rate	No recurrence clinically detected or by additional examen	10 years
Surgical complications rate	Dysphonia and hypocalcemia

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with uni or multifocal papillary microcarcinoma (cumulative size of foci <10mm) asymptomatic or not and who underwent partial or total thyroidectomy from 2012 to 2017.
Non opposition patient
Affiliation to a social security scheme

Exclusion Criteria:

Lesion crossing the thyroid capsule, or cervical lymph node involvement clinical or histological cervical lymph node involvement.
Patient under guardianship, curators or safeguard of justice

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with papillary microcarcinoma asymptomatic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Agnès DUPRET-BORIES, MD	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UHToulouse		Toulouse		31059	France

Condition Browse Module

MeSH Terms

ID	Term
D002291	Carcinoma, Papillary

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided