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Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care (PRiMAL)

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ClinicalTrials.gov Identifier: NCT05254795
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : December 14, 2023
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jill M Kolesar, University of Kentucky

Tracking Information
First Submitted Date  ICMJE February 14, 2022
First Posted Date  ICMJE February 24, 2022
Last Update Posted Date December 14, 2023
Actual Study Start Date  ICMJE April 13, 2022
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2022)
  • Overall survival [ Time Frame: 1 year ]
    Overall survival 1 year survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.
  • Change in quality of life (QOL) [ Time Frame: At enrollment, 8 weeks, and 12 weeks. ]
    Quality of life will be assessed via the FACT-L (The Functional Assessment of Cancer Therapy - Lung). FACT-L has 5 areas of measurement: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing, and an additional concerns list of problems specific to lung cancer. Areas are measured on a 5-point Likert-type scale of 0-4. The FACT-L subscales can be scored to yield a total score, subscale scores, as well as the Trial Outcome Index (TOI), which reflects the physical wellbeing, functional wellbeing, and lung cancer symptom subscales. TOI scores range from 0-84, with a higher score reflecting better QOL. Total FACT-G scores (physical, social, emotional, and functional wellbeing subscales) range from 0-108, with higher scores reflecting better QOL. The lung cancer subscale (i.e., additional concerns subscale) can range from 0-28 (only 7 items are scored), with higher scores reflecting better QOL.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2022)
  • Overall survival [ Time Frame: 1 year ]
    Comparison of overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care
  • Change in guideline concordant care [ Time Frame: 8 weeks, 12 weeks, and 1 year ]
    Comparison of guideline concordant care (specifically receiving next generation sequencing (NGS) testing and treatments based on identified mutations) between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.
  • Change in satisfaction with treatment [ Time Frame: At enrollment, 8 weeks, and 12 weeks. ]
    To compare satisfaction with treatment between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care, including financial, psychosocial, and physical measures of satisfaction using the Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) (version 4). The FACIT-TSG is an 8-item questionnaire, with each item score ranging from 0 ("not at all") to 4 ("very much"). Total scores range from 0 to 32 with higher scores indicating greater satisfaction with treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 14, 2022)		 Association of ctDNA variant allele frequency [ Time Frame: 1 year ]
To determine the association of ctDNA variant allele frequency with 1 year overall survival
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care
Official Title  ICMJE Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care
Brief Summary This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed stage IIb-IV Non-Small Cell Lung Cancer (NSCLC) and are planning to undergo treatment for their cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Other: Molecular tumor board assisted care
Participants in this group will obtain recommendations for care from the molecular tumor board.
Study Arms  ICMJE
  • No Intervention: Usual care recipients
  • Experimental: Molecular tumor board intervention
    Intervention: Other: Molecular tumor board assisted care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2022)		 500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2036
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically suspected or histologically confirmed stage IIb-IV NSCLC who are planning to undergo treatment
  • No prior systemic therapies for NSCLC, with the exception of adjuvant therapy for early stage NSCLC. Prior surgery and/or radiation is allowed.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jill Kolesar, PharmD, MS 859-323-4978 jill.kolesar@uky.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05254795
Other Study ID Numbers  ICMJE MCC-21-LUN-126-PMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Jill M Kolesar, University of Kentucky
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jill M Kolesar
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Principal Investigator: Jill Kolesar, PharmD, MS University of Kentucky
PRS Account University of Kentucky
Verification Date December 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP