Precision Oncology for Cancer

(PROGRESS Trial)

Overseen By Douglas Kirk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Active concurrent malignancy

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve cancer treatment through precision medicine, tailoring therapies based on individual genetic information. It focuses on patients with advanced breast, lung, colorectal, or bladder cancer. The study will determine if expert guidance and detailed genetic testing (next-generation sequencing or NGS) lead to better treatment choices and longer survival. This trial suits those with stage IV cancer planning to use genetic testing before their next treatment round. As an unphased trial, it offers a unique opportunity for patients to access cutting-edge genetic testing and expert guidance, potentially enhancing treatment outcomes.

Will I have to stop taking my current medications?

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

What prior data suggests that this precision oncology navigation is safe?

Research has shown that precision oncology navigation, where experts review advanced genetic test results, is generally well-tolerated. This method helps doctors choose the best treatments based on a patient's cancer genes. No new drugs are tested—only improved ways to use existing treatments.

Studies have demonstrated that using these genetic tests to guide cancer treatment does not introduce new safety risks. The safety of this process depends on treatments already approved by the FDA for cancer care, which are known to be safe when used correctly.

In summary, the precision oncology navigation process is safe because it doesn't involve new drugs. Instead, it focuses on selecting the best existing treatments for individual patients, which are already known to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Precision Oncology Navigation because it tailors cancer treatment to the individual by using genome-informed targeted therapy. Unlike traditional treatments that often take a one-size-fits-all approach, this method involves Next-Generation Sequencing (NGS) to analyze a patient's specific genetic makeup and identify the most effective treatment options. This approach can lead to more personalized and potentially more effective therapies for patients with stage IV solid tumors, such as breast, lung, colorectal, and bladder cancers. By focusing on the unique genetic profile of each cancer, Precision Oncology Navigation aims to improve outcomes and reduce unnecessary side effects.

What evidence suggests that precision oncology navigation is effective for stage IV solid tumor malignancies?

Research has shown that precision oncology navigation can significantly enhance treatment choices for cancer patients. In this trial, candidates for genome-informed targeted therapy will have a stage IV solid tumor malignancy (such as breast, lung, colorectal, or bladder cancer) and will undergo NGS testing before first or second-line therapy. Studies have found that examining the genes in cancer cells allows doctors to select treatments that specifically target the cancer's genetic makeup. For instance, breast cancer patients who received treatment based on their genetic information achieved better outcomes. This approach has led to more patients receiving targeted therapies that outperform traditional treatments. Overall, precision oncology is gaining popularity because it customizes treatment based on the unique genetic features of a person's cancer, potentially improving survival rates. ^{1 3 6 7 8}

Who Is on the Research Team?

Carrie Lee

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for stage IV solid tumor cancer patients, including those with breast, lung, colorectal, and bladder cancers. Participants must be eligible for genomic testing to guide therapy choices.

Inclusion Criteria

Subjects willing and able to comply with study procedures based on the judgment of the investigator

I can take care of myself but might not be able to do heavy physical work.

My doctor plans to use advanced genetic testing for my cancer treatment.

Exclusion Criteria

I have another active cancer besides the one being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and NGS Testing

Participants undergo Next Generation Sequencing (NGS) testing and expert review to facilitate genome-informed therapy (GIT) orders

12 months

Follow-up

Participants are monitored for overall survival and other outcomes after the return of NGS results

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Precision Oncology Navigation

Trial Overview The study tests if a precision oncology navigator and expert review of next-generation sequencing (NGS) results can increase the use of genome-informed therapies in advanced cancer treatment over historical rates.

How Is the Trial Designed?

Group I: The potential candidates for genome-informed targeted therapy Experimental Treatment 3 Interventions

Potential candidates have a stage IV solid tumor malignancy (breast, lung, colorectal, and bladder cancer) for whom NGS testing is planned to be obtained before first or second-line therapy.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

In a study of 322,887 cancer patients undergoing treatment, 19% experienced oncology-specific adverse events, with higher rates in those with metastatic cancers (41% for colorectal and 50% for lung cancer).

The most common triggers for these adverse events included abnormal serum bicarbonate levels and blood transfusions, highlighting the need for targeted monitoring in cancer care to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. Weingart, SN., Nelson, J., Koethe, B., et al.[2021]

In a multicenter clinical trial involving 152 lung cancer patients, the use of the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) allowed for high compliance in self-reporting adverse events, particularly during treatment (86% compliance).

The study demonstrated that patients were willing to self-report their symptoms using tablet computers, and identified that improving data collection methods, such as allowing electronic reporting between visits, could further enhance compliance and data quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Reporting of Symptomatic Adverse Events via the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a Chemoradiotherapy Cooperative Group Multicenter Clinical Trial. Basch, E., Pugh, SL., Dueck, AC., et al.[2022]

The North Central Cancer Treatment Group developed a real-time toxicity reporting system to enhance the monitoring of severe side effects in NCI-sponsored clinical trials, aiming to improve patient safety.

This system has been effective in monitoring phase II and III trials, such as the N9741 study on advanced colorectal cancer, allowing for timely modifications to ongoing clinical trials based on reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. Goldberg, RM., Sargent, DJ., Morton, RF., et al.[2016]

A new screening tool was developed to identify adverse events (AEs) in cancer care, consisting of 76 specific triggers that can help detect potential safety issues during treatment.

This tool, which categorizes triggers related to general care, vital signs, medications, and laboratory tests, has the potential to improve patient safety and quality of care in oncology, although further testing is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. Lipitz-Snyderman, A., Weingart, SN., Anderson, C., et al.[2021]

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

Patient navigation (PN) significantly increases patient satisfaction with cancer care according to a randomized controlled trial, showing a large effect size (SMD = 2.30), indicating its potential effectiveness in improving patient experiences.

However, non-randomized studies did not find a significant association between PN and satisfaction, suggesting that the quality of the study design may influence the perceived effectiveness of PN in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of patient navigation on satisfaction with cancer care: a systematic review and meta-analysis. Wells, KJ., Campbell, K., Kumar, A., et al.[2019]

The study developed and validated the Patient Satisfaction with Navigation, Logistical measure, which assesses patient navigation experiences in cancer treatment, using data from 1,873 diverse participants.

The measure demonstrated strong psychometric properties, providing reliable and precise scores for evaluating patient satisfaction with navigation services, which can help improve cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric evaluation of the patient satisfaction with logistical aspects of navigation (PSN-L) scale using item response theory. Carle, AC., Jean-Pierre, P., Winters, P., et al.[2021]

The Patient Satisfaction with Interpersonal Relationship with Navigator (PSN-I) measure was validated in a study involving 783 participants, demonstrating high internal consistency and reliability (α ranging from 0.95 to 0.96).

The PSN-I effectively captures patient satisfaction with navigators, showing strong correlations with existing satisfaction measures, which suggests it is a reliable tool for assessing the quality of support provided to underserved cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychometric development and reliability analysis of a patient satisfaction with interpersonal relationship with navigator measure: a multi-site patient navigation research program study. Jean-Pierre, P., Fiscella, K., Winters, PC., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06896162

PROGRESS: Precision Oncology Using Genomic Reflexive ... This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12346032/

Precision Oncology Guided by Genomic Profiling in Breast ... Data retrieved included patient characteristics, GP results, and MTB recommendations, which were consecutively matched with treatment outcomes, ...

3. bcan.org bcan.org/clinicaltrials/progress-precision-oncology-using-genomic-reflexive-evaluations-for-study-selection-and-survival/

PROGRESS: Precision Oncology Using Genomic Reflexive ... This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of ...

4. academic.oup.com academic.oup.com/jnci/article/117/6/1117/7972746

Comprehensive genome profiling for treatment decisions in ... Precision oncology, defined by the molecular profiling analysis of tumors to identify genetic alterations where a matched targeted treatment can be assigned, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11440300/

Nationwide precision oncology pilot study - PubMed Central Our study was designed to test the feasibility of a nationwide platform of NGS-guided MGT recommended by a central molecular tumor board (cMTB) for metastatic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11048446/

NGS-Guided Precision Oncology in Breast Cancer and ... Insights for precision oncology from the integration of genomic and clinical data of 13,880 tumors from the 100,000 Genomes Cancer Programme.

7. withpower.com withpower.com/trial/precision-oncology-for-cancer-a7183

Precision Oncology for Cancer (PROGRESS Trial) This trial is for stage IV solid tumor cancer patients, including those with breast, lung, colorectal, and bladder cancers. Participants must be eligible for ...

8. ascopubs.org ascopubs.org/doi/10.1200/PO.22.00715

Comprehensive Review on the Clinical Impact of Next ... This review summarizes the published evidence on the clinical impact of using next-generation sequencing (NGS) tests to guide management of patients with ...