NCT03878537

Brief Summary

This research study is investigating the role of cell free tumor DNA profiling in determining disease relapse and/or progression for patients with advanced NSCLC.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

March 14, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

March 14, 2019

Last Update Submit

March 21, 2021

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • Progression Free Survival

    Cell free tumor DNA based PFS

    24 months

  • Progression Free Survival

    Clinical or radiographic based PFS

    24 months

Eligibility Criteria

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

Patients aged 18 or older with NSCLC

You may qualify if:

  • Treatment naïve biopsy confirmed not surgically resectable stage III or greater NSCLC
  • Baseline CT imaging available

You may not qualify if:

  • Patients unable to undergo biopsy for initial tissue diagnosis
  • Patients who do not wish to pursue standard of care therapy
  • Patients with another diagnosis of malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scripps Health/Scripps Clinic Hillcrest/Scripps Clinic Torrey Pines

San Diego, California, 92103, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood specimens

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marin Xavier

    Scripps Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aditya Sarvaria

CONTACT

619-849-4469Sarvaria.Aditya@scripsshealth.org

Marin Xavier

CONTACT

619-849-4469Xavier.Marin@scrippshealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 18, 2019

Study Start

March 14, 2019

Primary Completion

March 1, 2021

Study Completion

December 31, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)