Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival (MIPTHYS)

June 19, 2023 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
        • UHToulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with papillary microcarcinoma asymptomatic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients with a papillary microcarcinoma asymptomatic
Adult patients who have had a papillary microcarcinoma asymptomatic and who are followed.
Other: Questionnaire
The questionnaire is about hypocalcemia, dysphonia and anxiety. It will be carried out by phone call for 10 minutes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: 10 years
No recurrence clinically detected or by additional examen
10 years
Surgical complications rate
Time Frame: 10 years
Dysphonia and hypocalcemia
10 years
Detection of recurrence rate
Time Frame: 10 years
Recurrence detection by additional examen
10 years
Recovery surgical or iratherapie recovery rate
Time Frame: 10 years
Anatomopathologic analysis
10 years
Anxiety evaluation
Time Frame: 1 month
Likert scale
1 month
Prognostics survival criteria
Time Frame: 1 month
Age during surgical
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Agnès DUPRET-BORIES, MD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 15, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 19, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0059
  • 2023-A00294-41 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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