Trial Outcomes & Findings for Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions (NCT NCT01457196)

Last Updated: 2019-12-30

Results Overview

To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified

Recruitment status

COMPLETED

Study phase

Target enrollment

2798 participants

Primary outcome timeframe

1 year

Results posted on

2019-12-30

Participant Flow

Of the 2798 participants screened for eligibility, 2074 were deemed eligible, 459 failed processing/sequencing, 226 had a sample collection failure, 19 were pediatric patients who were excluded from the final cohort, and 20 consents were withdrawn.

Participant milestones

Participant milestones
Measure	Sequencing Arm All eligible subjects who had Tumor Genetic Sequencing performed. This sequencing looked at genetic material from a sample of the subjects tumor and certain changes in the genetic material, to see if these changes are related to the subjects cancer.
Overall Study STARTED	2074
Overall Study COMPLETED	2074
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequencing Arm n=2074 Participants All eligible subjects who had Tumor Genetic Sequencing performed. This sequencing looked at genetic material from a sample of the subjects tumor and certain changes in the genetic material, to see if these changes are related to the subjects cancer.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	327 Participants n=5 Participants
Race (NIH/OMB) White	1573 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	125 Participants n=5 Participants
Region of Enrollment United States	2074 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1482 Participants n=5 Participants
Age, Categorical >=65 years	592 Participants n=5 Participants
Sex: Female, Male Female	1352 Participants n=5 Participants
Sex: Female, Male Male	722 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1972 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	35 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	13 Participants n=5 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified

Outcome measures

Outcome measures
Measure	Sequencing Arm n=2074 Participants Tumor Genetic Sequencing: This study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer.	Not Reported Subjects with next-generation sequencing who had no somatic variants identified by the UNC Molecular Tumor Board as actionable that were unknown at the time of testing reported to their treating physicians.
Proportion of Patients With a Reportable Genetic Variant	0.61 proportion of participants Interval 0.59 to 0.63	—

PRIMARY outcome

Timeframe: 2 Year

Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant

Outcome measures

Outcome measures
Measure	Sequencing Arm n=1267 Participants Tumor Genetic Sequencing: This study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer.	Not Reported n=807 Participants Subjects with next-generation sequencing who had no somatic variants identified by the UNC Molecular Tumor Board as actionable that were unknown at the time of testing reported to their treating physicians.
Progression Free Survival	31 percentage of participants Interval 26.0 to 37.0	62 percentage of participants Interval 53.0 to 70.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

To collect and describe clinical data including treatment outcomes after availability of results in patients

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Year

To compare progression free survival ratios between cancer patients with active disease with reportable genetic variant who were treated based on variant and those who were not treated based on a variant

Outcome measures

Outcome data not reported

Adverse Events

Sequencing Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 723 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robin Johnson

UNC Lineberger Comprehensive Cancer Center

Phone: 919-966-1125

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60