Active Surveillance Versus Surgery in Thyroid Papillary M... | NCT04129281

Studies
Active Surveillance Versus Surgery in Thyroid Papillary Microcarcinoma

NCT04129281

Sponsor

National Cancer Institute, Naples

Status

Unknown status

Last Update Posted

Mar 24, 2023Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Papillary Microcarcinoma of the Thyroid

Interventions

Surgery

Countries

Italy

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

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 23, 2019Actual

Primary Completion Date

Jan 23, 2024Estimated

Completion Date

Feb 23, 2024Estimated

First Submitted Date

Oct 15, 2019

First Submission Date that Met QC Criteria

Oct 15, 2019

First Posted Date

Oct 16, 2019Actual

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

Mar 23, 2023

Last Update Posted Date

Mar 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

Detailed Description

The primary objective of this study is to evaluate the outcome of two treatment approaches (immediate surgery or close follow-up) in patients with papillary thyroid microcarcinoma (mPTc) .

A further objective is to identify events associated with high risk of local recurrence and distant metastases.

Patients will be randomized to surgery or active surveillance. Patients who refuse the randomization process will be followed according to the treatment choice according to clinical practice.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery	Other	Surgery	Procedure: Surgery
Active surveillance	No Intervention	Follow up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Surgery acconding to clinical practice	Surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality of life in patient who received either surgery or follow up	EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) within 1 year from the diagnosis	36 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of life in patient who received either surgery or follow up	EORTC QLQ-C30, a quality of life questionnaires, composed by 30 items graded from1 (not at all) to 4 (very much) after 1 year from the diagnosis	36 months
Compare the two strategies in terms of anxiety/depression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age >or =18
Suspicious nodule < or = or 13 mm in the maximum size of thyroid ultrasound (not older than 3 months after the screening visit)
Cytology consistent with the TIR4 or TIR 5 class
Sieric TSH in th standard range (with or without levo-tyroxin therapy)
Normal string motility to fibrolaringoscopy
Written informed consent

Exclusion Criteria:

Ultrasound evidence of suspicious lump located on the posterior side of the lobe close to neurogene structures
Calcitonin increase above normal levels
Clinical or instrumental evidence of locoregional lymph node metastases (central or laterocervical compartment) or remote
any Contraindications to surgery

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Luciano Pezzullo	Contact	+39 0815903462		l.pezzullo@istitutotumori.na.it
Clorinda Schettino	Contact	+39 081 590 1791		c.schettino@istitutotumori.na.it

Overall Officials

Name	Affiliation	Role
Luciano Pezzullo	IRCCS Study Principal Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istitute Nazionale Tumori - Fondazione G. Pascale	Recruiting	Naples			Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C563277	Papillary Thyroid Microcarcinoma

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided