Strata EXPress™: A Study Using StrataEXP™ to Identify RNA-Expression Biomarkers in Advanced Cancer Patients

NCT05312307 | Withdrawn

• 1 other identifier: STR-006-001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary goal of this study is to identify patients with RNA expression profiles consistent with eligibility requirements for therapeutic clinical trials across solid tumors. Left-over tumor tissue will be collected from eligible participants for RNA expression analysis using next-generation sequencing.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• To identify subjects with RNA signatures who may be eligible for clinical trial enrollment

  The percentage of participants identified as eligible for therapeutic clinical trials.

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are male or female ≥ 18 years of age; must have pathologically confirmed advanced, metastatic, or recurrent solid tumor; measurable disease; have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; must meet at least 1 of the following: a. Is/has not adequately responded to standard therapy, or b. For whom no life extending standard therapy exists, or c. Who decline standard therapy, or d. In the opinion of the investigator, is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy; have adequate cardiac, bone marrow, organ function \& laboratory parameters as determined by the treating physician for potential participation in a clinical trial; have leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing.

You may qualify if:

• Must be ≥18 years of age,
• Participant must have pathologically confirmed advanced, metastatic, or recurrent solid tumor,
• Measurable disease,
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2,
• Participant must meet at least 1 of the following:
• Is/has not adequately responded to standard therapy, or
• For whom no life-extending standard therapy exists, or
• Who decline standard therapy, or
• In the opinion of the investigator, is not a candidate for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy
• Adequate cardiac, bone marrow, organ function \& laboratory parameters as determined by the treating physician for potential participation in a clinical trial,
• Leftover formalin-fixed, paraffin-embedded (FFPE) tumor tissue available for StrataEXP testing

You may not qualify if:

• Females who are pregnant or nursing,
• History of stroke including transient ischemic attack (TIA) or acute myocardial infarction within 4 months of enrollment,
• Any other clinically significant medical condition that, in the opinion of the treating physician, makes participation in a clinical trial undesirable, including but not limited to ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness.

Sponsors & Collaborators

• Strata Oncology: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kat Kwiatkowski, PhD

  Strata Oncology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: April 5, 2022
• Study Start: February 6, 2023
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share