NCT02678754

Brief Summary

This data collection Registry is a multi-center, observational outcomes Database designed to collect data on the demographics, presentation, diagnosis, treatment, resource use, quality of life and outcomes of subjects utilizing Caris Molecular Intelligence™ Services for treatment of solid tumor cancer.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
4,981

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

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

February 1, 2010

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

9.8 years

First QC Date

January 13, 2016

Last Update Submit

January 21, 2020

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Documentation of the frequency of specific clinical events in relation to risk factors, diagnosis and treatments provided.

    5 years per patient

Interventions

No intervention required, purely observationalOTHER

Eligibility Criteria

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

All patients seen within a physician practice participating in the Registry are potential candidates if they meet the eligibility criteria requirements

You may qualify if:

  • Age greater than or equal to 18 years, and
  • Solid Tumor analyzed by Caris Molecular Intelligence™ Service Profile(s) and/or Caris Next-Generation Sequencing

You may not qualify if:

  • Individual test orders; defined as single biomarker assessment
  • Due to the complexity of state and federal requirements governing the participation of prisoners in research, prisoner-patients shall not be approached for participation in the Registry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
9 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2016

First Posted

February 10, 2016

Study Start

February 1, 2010

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01