Neuroendocrine and Adrenal Tumors | NCT04432532

Studies
Neuroendocrine and Adrenal Tumors

NCT04432532

Sponsor

University of Pennsylvania

Status

Withdrawn

Last Update Posted

Feb 10, 2025Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Neuroendocrine Tumors
Adrenal Tumor

Interventions

No intervention

Countries

Not provided

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change in research direction

Expanded Access Info

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Jan 1, 2027Estimated

Completion Date

Jan 1, 2028Estimated

First Submitted Date

Mar 9, 2020

First Submission Date that Met QC Criteria

Jun 12, 2020

First Posted Date

Jun 16, 2020Actual

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

Feb 6, 2025

Last Update Posted Date

Feb 10, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Heather Wachtel, MD, Assistant Professor of Surgery, University of PennsylvaniaPrincipal Investigator

Lead Sponsor

University of PennsylvaniaOTHER

Collaborators

Not provided

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

This is a prospective study of rare neuroendocrine and adrenal tumors. Subjects will be enrolled via informed consent, and blood and/or saliva and tissue will be collected. This is designed to work in conjunction with IRB#831990 which is a retrospective protocol. The University of Pennsylvania will be a contributing site with the University of Michigan as the coordinating site for the A5 alliance, a multi-institutional collaborative designed to study neuroendocrine and adrenal tumors.

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

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neuroendocrine Tumor			Other: No intervention
Adrenal Tumor			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	There are no interventions	Adrenal Tumor Neuroendocrine Tumor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival		10 years

Secondary Outcomes

Measure	Description	Time Frame
Tumor Recurrence	We want to record recurrences in our patient population	10 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosed with neuroendocrine and/or an adrenal tumor

Exclusion Criteria:

pregnant women
prisoners
people under the age of 18

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed and seeking treatment for neuroendocrine tumors or adrenal tumors

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018358	Neuroendocrine Tumors
D000310	Adrenal Gland Neoplasms

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided