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Genome Sequencing for Cancer (PE-CGS Trial)

N/A

Recruiting

Led By Cheryl Willman, MD

Research Sponsored by New Mexico Cancer Care Alliance

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The PE-CGS Research Center is only recruiting and sequencing tumors for adult-onset cancers (patients and survivors) among the American Indian Tribes, Nations, and Pueblos of New Mexico and adjacent states

Be older than 18 years old

Must not have

Cognitively impaired

Adults unable to consent for themselves

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at ways to recruit American Indians from Southwestern Tribal Nations for cancer genome sequencing. American Indians in this region have higher rates of certain types of cancer, and they may also have shorter

Who is the study for?

This trial is for adult American Indians from Southwestern Tribal Nations who have cancer or are survivors. Participants must be adults able to consent, self-identify as American Indian, and belong to tribes in New Mexico or nearby states. It excludes those cognitively impaired, unable to consent, not yet adults, or prisoners.

What is being tested?

The study is exploring how best to engage American Indians of the Southwest in cancer genome sequencing. It involves survey administration, returning results to participants, and collecting biospecimens like tissue samples from tumors.

What are the potential side effects?

Since this trial does not involve drugs but rather surveys and sample collection, there are no direct side effects related to medications. However, participants may experience discomfort or emotional distress during sample collection or upon receiving personal genetic information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult cancer patient or survivor from an American Indian community in New Mexico or nearby.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have difficulty with thinking or memory.

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I am unable to make medical decisions for myself.

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I am under the age of 18.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biospecimen participation rate

Data participation rate

Rate of Preparatory and Optimization Phase completion

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Category 1 (biospecimens, surveys, interviews)Experimental Treatment3 Interventions

Cancer patients and survivors undergo collection of tissue, blood, saliva, and stool samples on study for genomic sequencing and microbiome analysis. Cancer patients and survivors also complete surveys and interviews on study pre and post intervention.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

0 / 4Eligibility criteria met