Thyroid Cancer Database | NCT04031638

Studies
Thyroid Cancer Database

NCT04031638

Sponsor

Centre Georges Francois Leclerc

Status

Unknown status

Last Update Posted

Jul 24, 2019Actual

Enrollment

2,300Estimated

Phase

Not provided

Conditions

Patients With a Thyroid Tumor Who Received Radioactive Iodine Treatment

Interventions

Radioactive Iodine treatment

Countries

France

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

Jul 2019

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 1, 2000Actual

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Jan 1, 2025Estimated

First Submitted Date

Jul 1, 2019

First Submission Date that Met QC Criteria

Jul 23, 2019

First Posted Date

Jul 24, 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

Jul 23, 2019

Last Update Posted Date

Jul 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Thyroid cancer database collects clinical and laboratory data from patients with a thyroid tumor who received radioactive Iodine treatment. This database only records information based on patients' medical files in a structured manner.

Thyroid database is used for retrospective non-interventional research projects.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radioactive Iodine treatment for thyroid cancer			Other: Radioactive Iodine treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radioactive Iodine treatment	Other	Patients with a thyroid tumor who received radioactive Iodine treatment.	Radioactive Iodine treatment for thyroid cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient survival	Overall survival and evolution over years	10 years

Secondary Outcomes

Measure	Description	Time Frame
Collection of patient and treatment characteristics	Collection of patient and treatment characteristics over years, to set up prospective and retrospective studies	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with a thyroid tumor (metastatic or not)
patients who received radioactive Iodine treatment.
age >= 18

Exclusion Criteria:

Objection to collect medical data records

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

Patients with a thyroid tumor who received radioactive Iodine treatment in Centre Georges Francois Leclerc, Dijon, France

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
AURELIE BERTAUT, MD, PhD	Contact	+33 3 80 73 77 84		ABertaut@cgfl.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodology, Biostatistics and Data Management	Recruiting	Dijon			France

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
D013964	Thyroid Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided