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

• Sponsor: University Hospital, Toulouse (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05873361
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 10.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Papillary Carcinoma	Other: Questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 500 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Interest of Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival
• Actual Study Start Date: May 15, 2023
• Anticipated Primary Completion Date: May 15, 2027
• Anticipated Study Completion Date: May 15, 2027

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Overall survival [10 years]

   Review of medical record

Secondary Outcome Measures

1. Disease control rate [10 years]

   No recurrence clinically detected or by additional examen

2. Surgical complications rate [10 years]

   Dysphonia and hypocalcemia

3. Detection of recurrence rate [10 years]

   Recurrence detection by additional examen

4. Recovery surgical or iratherapie recovery rate [10 years]

   Anatomopathologic analysis

5. Anxiety evaluation [15 minutes]

   Likert scale

6. Prognostics survival criteria [1 day]

   Age during surgical

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UHToulouse	Toulouse		France	31059

Sponsors and Collaborators

• University Hospital, Toulouse

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Toulouse
• ClinicalTrials.gov Identifier: NCT05873361
• Other Study ID Numbers: RC31/23/0059; 2023-A00294-41
• First Posted: May 24, 2023
• Last Update Posted: May 24, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Toulouse: Papillary Carcinoma, postoperative, follow-up
• Additional relevant MeSH terms: Carcinoma, Papillary

Study Results

No Results Posted as of May 24, 2023