NCT02747355

Brief Summary

In adrenal tumors, the investigators will examine if there is any correlation between WIESS criteria, prognosis of the tumor, and the different labeling index of the following proliferation biomarkers: MCM3, MCM2, KI-67, P53, NEUROPILIN -1, METALLOTHIONEIN, SEMAPHORIN-3A.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

April 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 18, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

January 18, 2019

Status Verified

January 1, 2019

Enrollment Period

1.9 years

First QC Date

April 19, 2016

Last Update Submit

January 17, 2019

Conditions

Adrenal Cortex NeoplasmsAdrenal Cortex Diseases

Outcome Measures

Primary Outcomes (7)

  • MCM3 expression

    Difference in MCM3 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma

    1 year

  • MCM2 expression

    Difference in MCM2 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma

    1 year

  • P53 expression

    Difference in P53 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma

    1 year

  • NEUROPILIN -1 expression

    Difference in NEUROPILIN -1 labeling index between adrenal cortical adenoma versus adrenocortical carcinoma

    1 year

  • METALLOTHIONEIN expression

    Difference in METALLOTHIONEIN labeling index between adrenal cortical adenoma versus adrenocortical carcinoma

    1 year

  • SEMAPHORIN-3A expression

    Difference in SEMAPHORIN-3A labeling index between adrenal cortical adenoma versus adrenocortical carcinoma

    1 year

  • E-caderein expression

    Difference in E-caderein labeling index between adrenal cortical adenoma versus adrenocortical carcinoma

    1 year

Secondary Outcomes (2)

  • KI67

    1 year

  • Prognosis

    1 year

Eligibility Criteria

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

Adrenal tissue from patients diagnosed with adrenocortical carcinoma, adrenal adenoma and normal adrenals from patients who had renal and adrenal excision for renal cancer

You may qualify if:

  • adrenal carcinoma
  • adrenal adenoma
  • normal adrenal tissue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

adrenal tissue

MeSH Terms

Conditions

Adrenal Cortex NeoplasmsAdrenal Cortex Diseases

Condition Hierarchy (Ancestors)

Adrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 19, 2016

First Posted

April 21, 2016

Study Start

August 18, 2016

Primary Completion

July 1, 2018

Study Completion

December 1, 2019

Last Updated

January 18, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will share