TABLE OF CONTENTS

Overview

Patient Brochure

Clinician Patient Referral Guide

Clinician Referral Form

Patient Eligibility

Institutional Partnership Introduction

TargeTx Study Summary

How to Refer

FAQ

Appendices

CANCER HUNT INITIATIVE

TargeTx Study Summary

TARGETx — Tumor Analysis of Rates of Genomic Evidence for Targeted Treatment


STUDY OVERVIEW

Study type

Minimal-risk biospecimen, genomic profiling, navigation, and research study. IRB-supported. Not a treatment trial — TargeTx does not direct therapy, replace the treating oncologist, or require changes in standard-of-care.

Sponsors

SOTERIA Precision Medicine Foundation in conjunction with TGen (City of Hope) for research-use-only WGS analysis and multidisciplinary Molecular Tumor Board review.

Population

U.S. military veterans with active cancer diagnoses. Typically stage IIIB–IV. Earlier stage considered at investigator discretion.

ELIGIBILITY OVERVIEW

Participants are generally eligible if they meet all of the following:

  • Age 18 or older

  • Active cancer diagnosis — primarily solid tumors; brain and blood cancers evaluated individually

  • Stage IIIB–IV preferred; earlier stage considered at investigator discretion

  • Accessible medical records

  • Available tumor tissue or cells from prior or upcoming standard-of-care biopsy or resection — no research-only biopsy required

  • Willing to donate residual biospecimens

  • Willing to engage with SOTERIA nurse navigation

Note: Protocol allows investigator discretion for earlier-stage cancers and selected Intelligence Community field-agent cases.

Research-use only (RUO — TGen)

  • Mutational signature analysis

  • Copy-number analysis

  • RNA / transcriptome analysis

  • Comparison with public datasets

RUO findings are not returned directly to participants and require clinical validation before clinical use. CLIA-validated reports are returned to SOTERIA, the participant, and the treating physician.

PROTOCOL FLOW

  • Identification & intake: SOTERIA consents eligible participants, consolidates medical records

  • Tissue coordination: FFPE, fresh frozen, saliva, buccal swab, or blood; from prior or clinically indicated procedures only

  • Sequencing: CLIA-certified labs for clinical testing; TGen for RUO analysis

  • Molecular Tumor Board: convened for select cases; treating physicians invited

  • Results delivery: CLIA reports returned to patient and treating team; plain-language summary prepared by SOTERIA

  • Longitudinal follow-up: outcomes tracking, treatment response, exposureomics analysis

KEY OBJECTIVES

Primary: Measure the frequency of potentially treatment-relevant genomic targets identified in tumors from U.S. military personnel.

Secondary: Sample procurement time, testing turnaround, time to return of results, cancer types represented, patient satisfaction with navigation.

Exploratory: Identify molecular signatures, compare findings with non-military datasets, collect outcomes data, and characterize exposure-linked patterns.

TESTING & SEQUENCING

Clinical testing (CLIA-certified)

  • Whole Exome Sequencing (WES) — tumor/normal

  • Whole Transcriptome Sequencing (WTS)

  • Whole Genome Sequencing for selected indications

  • Germline panel (BRCA1/2, ATM, CDK12, and others)

CLINICAL & REFERRAL INQUIRIES

Amanda Skeen

Co-Founder & COO

amanda@soteriapmf.org

VETERAN COMMUNITY OUTREACH

Rob Newson

Chief Community Officer | Retired SEAL

619-203-3524 | rob@soteriapmf.org

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