NCT01649453

Brief Summary

The study prospectively assesses the change in cancer-specific clinical decisions and outcomes before and after physicians received results from the Pathwork® Tissue of Origin (TOO) Test for patients whose primary site of cancer origin is uncertain.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

8 months

First QC Date

July 23, 2012

Last Update Submit

March 4, 2013

Conditions

Neoplasm Metastasis

Keywords

NeoplasmsNeoplasm MetastasisNeoplastic ProcessesPathologic Processes

Outcome Measures

Primary Outcomes (1)

  • Survival

    2 years

Study Arms (1)

Cancer of uncertain primary

Device: Pathwork® Tissue of Origin Test

Interventions

Pathwork® Tissue of Origin TestDEVICE
Also known as: Gene expression profile tissue of origin test
Cancer of uncertain primary

Eligibility Criteria

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

Community and academic clinics

You may qualify if:

  • their physician ordered or intends to order a Pathwork® TOO Test between May 2012 and December 2013
  • the patient is ≥ 18 years of age
  • the patient has given informed consent (online or verbal)
  • the patient is able to understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedar Associates LLC

Menlo Park, California, 94025, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue biopsy specimen.

MeSH Terms

Conditions

Neoplasm MetastasisNeoplasmsNeoplastic ProcessesPathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

  • John Hornberger, MD MS

    Cedar Associates LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO, President

Study Record Dates

First Submitted

July 23, 2012

First Posted

July 25, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

US(1)