Papillary CarcinomaMIPTHYSNCT05873361
Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival
An observational study of Papillary Carcinoma, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Carcinoma
- What is being tested?
- Questionnaire
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2023to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with papillary microcarcinoma asymptomatic
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Papillary Carcinoma
- Being tested
- Questionnaire
- Keywords
- Papillary Carcinoma, Postoperative, Follow-up
- Medical subject headings
- Carcinoma, Papillary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The questionnaire is about hypocalcemia, dysphonia and anxiety. It will be carried out by phone call for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with a papillary microcarcinoma asymptomatic | Adult patients who have had a papillary microcarcinoma asymptomatic and who are followed. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Review of medical record
Measured: 10 years
Secondary outcomes (6)
Disease control rate
No recurrence clinically detected or by additional examen
Measured: 10 years
Surgical complications rate
Dysphonia and hypocalcemia
Measured: 10 years
Detection of recurrence rate
Recurrence detection by additional examen
Measured: 10 years
Recovery surgical or iratherapie recovery rate
Anatomopathologic analysis
Measured: 10 years
Anxiety evaluation
Likert scale
Measured: 1 month
Prognostics survival criteria
Age during surgical
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start15 May 2023
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papillary CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès DUPRET-BORIES, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05873361
- Sponsor's protocol ID
- RC31/23/0059
- Other IDs
- 2023-A00294-41
- Acronym
- MIPTHYS
- Status last verified
- Jun 2023
- First submitted
- 15 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Postoperative Follow-up of Asymptomatic Papillary Microcarcinomas on Patient Survival
- ClinicalTrials.gov ID
- NCT05873361
- Acronym / sponsor ID
- MIPTHYS / RC31/23/0059
- Conditions
- Papillary Carcinoma
- Keywords
- Papillary Carcinoma, Postoperative, Follow-up
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with a papillary microcarcinoma asymptomatic | – | Other: QuestionnaireAdult patients who have had a papillary microcarcinoma asymptomatic and who are followed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with papillary microcarcinoma asymptomatic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireThe questionnaire is about hypocalcemia, dysphonia and anxiety. It will be carried out by phone call for 10 minutes | Other | Adult patients with a papillary microcarcinoma asymptomatic |
Primary outcome
Overall survival
Time frame: 10 years
Review of medical record
6 secondary outcomes
Disease control rate
Time frame: 10 years
Surgical complications rate
Time frame: 10 years
Detection of recurrence rate
Time frame: 10 years
Recovery surgical or iratherapie recovery rate
Time frame: 10 years
Anxiety evaluation
Time frame: 1 month
Prognostics survival criteria
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnès DUPRET-BORIES, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Papillary Carcinoma, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.