NCT05873361

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress75%
May 2023May 2027

First Submitted

Initial submission to the registry

May 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2027

Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

4 years

First QC Date

May 15, 2023

Last Update Submit

June 19, 2023

Conditions

Keywords

Papillary CarcinomaPostoperativeFollow-up

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Review of medical record

    10 years

Secondary Outcomes (6)

  • Disease control rate

    10 years

  • Surgical complications rate

    10 years

  • Detection of recurrence rate

    10 years

  • Recovery surgical or iratherapie recovery rate

    10 years

  • Anxiety evaluation

    1 month

  • +1 more secondary outcomes

Study Arms (1)

Adult patients with a papillary microcarcinoma asymptomatic

Adult patients who have had a papillary microcarcinoma asymptomatic and who are followed.

Other: Questionnaire

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with papillary microcarcinoma asymptomatic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHToulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Carcinoma, Papillary

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Agnès DUPRET-BORIES, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2023

First Posted

May 24, 2023

Study Start

May 15, 2023

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations