Genome Sequencing for Cancer

(PE-CGS Trial)

Overseen By Ursa Brown-Glaberman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: New Mexico Cancer Care Alliance

Disqualifiers: Cognitively impaired, unable to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1001 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies engagement strategies for recruiting American Indians (AI) of Southwestern Tribal Nations for cancer genome sequencing. American Indians in the Southwest have higher rates of some types of cancer, such as cancers that arise in the liver, kidney, breast, and colon. American Indians with cancer may also live for less time than people from other population groups who have been treated for the same cancer. Damage to the cells of the body, acquired as people live, grow older, and are exposed to the environment, causes genetic changes in cells that can lead to cancer. This study may help researchers learn how these genetic changes in cells cause cancer and understand how and why cancer is arising in American Indians in the Southwest. This may help better prevent and treat cancer in the future.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Biospecimen Collection, Return of Results, Survey Administration for cancer?

The 'Cancer 2015' study shows that genomic testing can identify actionable mutations in cancer patients, which can guide personalized treatment decisions. Additionally, the HOPE breast cancer study suggests that using genomic data in treatment planning can improve outcomes for patients with metastatic breast cancer. ^{1 2 3 4 5}

Is genome sequencing for cancer generally safe for humans?

The research articles provided do not contain specific safety data about genome sequencing for cancer, but they discuss participant attitudes and preferences regarding data privacy and the return of results. No direct safety concerns related to the genome sequencing process itself are mentioned. ^{6 7 8 9 10}

How does genome sequencing for cancer differ from other treatments?

Genome sequencing for cancer is unique because it involves analyzing a patient's genetic information to identify specific mutations that may be driving their cancer. This approach allows for personalized treatment plans, potentially leading to more effective and targeted therapies compared to traditional treatments that do not consider individual genetic variations. ^{1 2 11 12 13}

Research Team

Cheryl Willman, MD

Principal Investigator

University of New Mexico Comprehensive Cancer Center

Ursa Brown-Glaberman, MD

Principal Investigator

University of New Mexico Comprehensive Cancer Center

Andrew Sussman, PhD

Principal Investigator

University of New Mexico Comprehensive Cancer Center

Shiraz I Mishra, MCCS, PhD

Principal Investigator

University of New Mexico Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

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

I am currently receiving cancer treatment or have survived cancer.

Self-identify as American Indian

Exclusion Criteria

I have difficulty with thinking or memory.

I am unable to make medical decisions for myself.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Engagement and Recruitment

Direct participant engagement with cancer patients/survivors, community advisors, and partners to refine and optimize methods/processes; identify, recruit and consent eligible AI cancer patients/survivors

Up to 18 months

Sample Collection and Data Gathering

Collection of tissue, blood, saliva, and stool samples for genomic sequencing and microbiome analysis; completion of surveys and interviews pre and post intervention

Up to 18 months

Return of Results and Counseling

Return clinical grade and clinically useful genomic data to participants with navigation to counseling and clinical resources as warranted

Up to 18 months

Follow-up

Participants are monitored for safety and effectiveness after genomic data return and potential therapeutic interventions

4-8 weeks

Treatment Details

Interventions

• Biospecimen Collection
• Return of Results
• Survey Administration

Trial Overview 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.

Participant Groups

Group I: Category 1 (biospecimens, surveys, interviews) Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

New Mexico Cancer Care Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

New Mexico Cancer Research Alliance

Lead Sponsor

Trials

71

Recruited

52,500+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A study involving interviews with patients and clinicians in a precision oncology setting revealed that many participants were unaware that consent forms allowed for the commercialization of their genetic data, raising concerns about profit distribution and privacy.

Patients generally showed more comfort with commercialization compared to clinicians, highlighting a need for better education and transparency regarding the commercialization process in precision oncology to build trust and understanding among all stakeholders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"My Research Is Their Business, but I'm Not Their Business": Patient and Clinician Perspectives on Commercialization of Precision Oncology Data. Spector-Bagdady, K., Krenz, CD., Brummel, C., et al.[2022]

The 'Cancer 2015' study successfully recruited 1685 patients over nearly 3 years, establishing a large population-based genomics cohort for patients with solid cancers, which is crucial for future research and clinical applications.

About 10% of the tumors sequenced contained potentially actionable somatic mutations, highlighting the potential for precision medicine to guide treatment decisions, while 42% of patients had no mutations identified, indicating variability in genomic profiles among cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Cancer 2015": A Prospective, Population-Based Cancer Cohort-Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic. Parisot, JP., Thorne, H., Fellowes, A., et al.[2020]

Real-world clinical data from electronic health records and genomic data from tumor profiling can be combined to enhance precision medicine for cancer patients, despite the challenges in linking and ensuring data quality.

A proposed approach to create a clinico-genomic database aims to leverage routine patient care data to generate generalizable evidence, suggesting that supportive health policies could facilitate innovation in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Evidence In Support Of Precision Medicine: Clinico-Genomic Cancer Data As A Case Study. Agarwala, V., Khozin, S., Singal, G., et al.[2019]

The study analyzed metastasis and organotropism in a large cohort of 25,775 patients using targeted panel sequencing and electronic health record data, providing valuable insights into cancer spread.

The genomic and clinical data from this research have been made freely available, serving as a significant resource for further studies in the cancer research community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastasis and organotropism: A look through the lens of large-scale clinical sequencing data. Coulton, A., Turajlic, S.[2022]

The HOPE trial empowers metastatic breast cancer patients by allowing them to actively participate in their treatment decisions through a digital tool, which includes access to next-generation sequencing (NGS) for personalized medicine.

The study aims to gather real-world data on the clinical utility of molecular information in managing metastatic breast cancer, with a focus on patient-centric approaches and educational support, potentially improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HOPE (SOLTI-1903) breast cancer study: real-world, patient-centric, clinical practice study to assess the impact of genomic data on next treatment decision-choice in patients with locally advanced or metastatic breast cancer. Olivera-Salguero, R., Seguí, E., Cejalvo, JM., et al.[2023]

A study involving 450 participants from the Northwest Cancer Genetics Registry found that most individuals were not worried about personal identification in genetic studies using de-identified data, but they emphasized the importance of privacy protection.

Participants generally supported the use of their de-identified data for multiple research studies, as they believed it could enhance their chances of receiving personal health information, although about 20% preferred that no link be maintained between them and their de-identified data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-identified genomic data sharing: the research participant perspective. Goodman, D., Johnson, CO., Bowen, D., et al.[2022]

In a study involving 60 young women diagnosed with breast cancer, there was a strong interest in receiving actionable genomic results that could influence treatment or prevention strategies.

Participants expressed a desire for the ability to choose which genomic results they receive, indicating that not all findings are equally valued, especially those perceived as non-actionable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for return of incidental findings from genome sequencing among women diagnosed with breast cancer at a young age. Kaphingst, KA., Ivanovich, J., Biesecker, BB., et al.[2018]

A new visual mapping tool has been developed to systematically depict the process of collecting specimens, creating data sets, performing analyses, and generating genetic results in biobank research, which helps in understanding incidental findings (IFs) and individual research results (IRRs).

This tool can be applied across different biobank systems to anticipate the types of IFs and IRRs that may arise, aiding in responsible management and informing policy development regarding the return of these findings to research participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping the inputs, analyses, and outputs of biobank research systems to identify sources of incidental findings and individual research results for potential return to participants. Bemmels, HR., Wolf, SM., Van Ness, B.[2022]

A strategic insurance review of a cancer biobank identified both inherent and residual risks that could impact its maintenance, highlighting the importance of risk assessment in biobanks.

The review revealed significant intrinsic risks but also noted that improvements have been made to mitigate these risks, enhancing the biobank's overall safety and reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification and Assessment of Risks in Biobanking: The Case of the Cancer Institute of Bari. De Palma, G., Bolondi, G., Tufaro, A., et al.[2022]

A significant majority of cancer patients in the study (87.1% for tissue and 83.3% for blood) expressed willingness to donate leftover samples for research, indicating strong support for biospecimen collection in cancer research.

Factors such as gender, age, first hospitalization, and education level influenced patients' willingness to donate, suggesting that targeted education efforts could enhance participation in biobanking activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes and Perceptions of Cancer Patients Toward Biospecimen Donation for Cancer Research: A Cross-Sectional Survey Among Chinese Cancer Patients. He, N., Guo, Y., He, M., et al.[2018]

The biobanking initiative has successfully collected 23,226 samples from 1,711 patients and controls over nearly two years, focusing on common cancers like breast, colorectal, and prostate carcinomas, which will aid in understanding genetic predispositions to these diseases.

With 40% of samples coming from healthy tissue adjacent to tumors, this unique collection allows for comprehensive '-omics' research, potentially revealing critical insights into the genetic mechanisms of cancer development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive cancer-oriented biobanking resource of human samples for studies of post-zygotic genetic variation involved in cancer predisposition. Filipowicz, N., Drężek, K., Horbacz, M., et al.[2023]

This study evaluated the quality of next-generation sequencing data from tissue samples collected in Bristol Myers Squibb Immuno-Oncology clinical trials, using a modeling approach based on whole exome sequencing quality control metrics.

Most tissue collection sites performed well in terms of sample quality, but identifying sites with poor performance can help improve overall sample quality and reduce the risk of sample failure in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling performance of sample collection sites using whole exome sequencing metrics. Kalinava, N., Apfel, A., Cartmell, R., et al.[2022]

A study of 59 archived FFPE ovarian cancer tissues showed that 98% of samples yielded sufficient DNA for Next Generation Sequencing (NGS), indicating that FFPE specimens can be a valuable resource for cancer research.

While longer storage times negatively impacted the quality of the DNA (lower coverage and read depth), 90% of the specimens still provided usable NGS data, suggesting that FFPE tissues can be effectively utilized in population-based cancer studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robustness of Next Generation Sequencing on Older Formalin-Fixed Paraffin-Embedded Tissue. Carrick, DM., Mehaffey, MG., Sachs, MC., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

"My Research Is Their Business, but I'm Not Their Business": Patient and Clinician Perspectives on Commercialization of Precision Oncology Data. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

"Cancer 2015": A Prospective, Population-Based Cancer Cohort-Phase 1: Feasibility of Genomics-Guided Precision Medicine in the Clinic. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Real-World Evidence In Support Of Precision Medicine: Clinico-Genomic Cancer Data As A Case Study. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Metastasis and organotropism: A look through the lens of large-scale clinical sequencing data. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

HOPE (SOLTI-1903) breast cancer study: real-world, patient-centric, clinical practice study to assess the impact of genomic data on next treatment decision-choice in patients with locally advanced or metastatic breast cancer. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

De-identified genomic data sharing: the research participant perspective. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

Preferences for return of incidental findings from genome sequencing among women diagnosed with breast cancer at a young age. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Mapping the inputs, analyses, and outputs of biobank research systems to identify sources of incidental findings and individual research results for potential return to participants. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Identification and Assessment of Risks in Biobanking: The Case of the Cancer Institute of Bari. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Attitudes and Perceptions of Cancer Patients Toward Biospecimen Donation for Cancer Research: A Cross-Sectional Survey Among Chinese Cancer Patients. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Comprehensive cancer-oriented biobanking resource of human samples for studies of post-zygotic genetic variation involved in cancer predisposition. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Modeling performance of sample collection sites using whole exome sequencing metrics. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Robustness of Next Generation Sequencing on Older Formalin-Fixed Paraffin-Embedded Tissue. [2022]