Screening Platform for Cancer Eligibility

Recruiting at 102 trial locations

Overseen By Reference Study ID Number: BX43361 https://forpatients.roche.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hoffmann-La Roche

Disqualifiers: Other malignancies, Liver disease, Cardiovascular disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

15000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if specific biomarkers (unique biological markers) in tumor tissue can qualify participants for another Roche clinical trial. It targets individuals with non-small cell lung cancer (NSCLC) to assess their eligibility for further treatment studies. Participants should have advanced NSCLC that cannot be surgically removed and must be in good physical condition, as indicated by an ECOG performance status of 0, 1, or 2, meaning they can perform daily activities with little difficulty. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

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 screening platform is safe?

Research has shown that screening tools like the one used in this trial are generally safe for participants. These tools identify specific markers in the body to help match participants with the right clinical trial.

As a Phase 2 trial, the treatment has already demonstrated positive results in earlier tests. Phase 2 trials assess how well a treatment works and monitor for any side effects. By this stage, researchers usually know of any serious side effects, and the treatment is considered fairly safe. However, some mild side effects might still occur.

For specific concerns, discussing them with the research team or a doctor can provide more details about what to expect.

Why are researchers excited about this trial?

Researchers are excited about the Screening Platform for Cancer Eligibility because it offers a novel way to identify which patients with Non-Small Cell Lung Cancer (NSCLC) might benefit from specific treatments based on their unique biomarkers. Unlike standard treatments that follow a one-size-fits-all approach, this platform aims to tailor treatment plans to the individual, potentially increasing efficacy and minimizing unnecessary side effects. By focusing on biomarker eligibility, the platform could pave the way for more personalized and effective cancer care, ultimately improving outcomes for patients.

What evidence suggests that this screening platform is effective for determining cancer eligibility?

Research has shown that testing for certain markers in the body can help identify the best treatments for cancer patients. In past studies, identifying specific markers in tumors helped doctors select optimal treatment plans for individuals with non-small cell lung cancer (NSCLC). These markers are substances in the body that can indicate how well a treatment might work. Detecting these markers can lead to more personalized and potentially more effective treatment options. In this trial, participants with NSCLC will undergo screening for biomarker eligibility to determine the most suitable treatment options based on their unique tumor characteristics.

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

This trial is for people with solid tumors who have a tumor sample available and are considered candidates for an upcoming clinical trial. They must be willing to participate in the new trial. People with significant liver or heart disease, other recent cancers (except certain low-risk types), or past organ transplants cannot join.

Inclusion Criteria

I have a tumor sample preserved and ready for testing.

Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial

Exclusion Criteria

I haven't had any cancer other than NSCLC in the last 5 years, except for very low-risk types.

I have had a previous transplant of an organ or stem cells from another person.

Any condition that may affect the interpretation of study results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biomarker Assessment

Participants' tumor tissue is assessed to determine biomarker status for eligibility in a linked Roche clinical trial

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after biomarker assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Screening platform

Trial Overview The study aims to analyze participants' tumor samples to identify specific biomarkers. These findings will determine if they can enter a linked Roche clinical trial that tests new cancer treatments.

How Is the Trial Designed?

Group I: Non-Small Cell Lung Cancer (NSCLC) Experimental Treatment 1 Intervention

Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

A new computerized database has been developed to monitor cancer prevention and screening practices across Europe, which can help reduce costs and improve health policy decisions.

The system is designed to analyze various factors related to cancer screening, such as patient demographics and medical history, and is available in multiple languages to facilitate its use across different European countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SESy-Europe: a multi-language database dedicated to cancer screening monitoring. Mauri, D., Pazarlis, P., Mauri, J., et al.[2007]

Breast cancer screening programs, particularly mammography, are supported for continuation despite concerns about false positives and overdiagnosis, which can negatively affect women's lives.

Future efforts should focus on developing risk-based screening strategies to improve the balance of benefits and harms, ensuring that women and their doctors can make informed decisions about screening options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The balance sheet of benefits and harms of breast cancer population-based screening in Europe: outcome research, practice and future challenges. Broeders, M., Paci, E.[2015]

Effective cancer screening relies on well-defined criteria and organized systems to identify individuals with hidden diseases, which can lead to reduced morbidity and mortality.

Successful screening programs require high participation rates, quality control, and ongoing evaluation to maximize their potential benefits; without proper organization, the effectiveness of screening may be compromised.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Principles of successful cancer screening. Smith, RA.[2016]

The study proposes an improved patient flow arrangement to enhance the convenience and effectiveness of population screening for malignant tumors and precancerous diseases.

It outlines a mass-screening system that incorporates medical and computer techniques to optimize oncological screening processes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Aspects of providing the equipment for mass screening systems for the early detection of oncological diseases]. Gundarov, VP., Shubin, BM., Shirokov, VS., et al.[2006]

Hepatocellular carcinoma (HCC) has a very low 5-year survival rate of less than 20%, largely due to failures in the cancer screening process, including underutilization of screening in at-risk patients and inadequate treatment options.

A conceptual model was developed to identify specific steps in the HCC screening process that are prone to delays or failures, highlighting the need for targeted interventions to improve early detection and reduce mortality, similar to successful strategies used in breast and colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual Model for the Hepatocellular Carcinoma Screening Continuum: Current Status and Research Agenda. Singal, AG., Lok, AS., Feng, Z., et al.[2023]

In 2013, a total of 305,568 women were screened for breast cancer, 3,160,128 for cervical cancer, and 2,363,922 for colorectal cancer, with high rates of being up-to-date on screenings: 63.5% for breast, 84.6% for cervical, and 77.5% for colorectal.

The follow-up for abnormal screens was very high, with 96.8% for breast cancer, and around 76% for cervical and colorectal cancers, indicating effective diagnostic evaluation processes in place for these screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Screening Participation, Follow-up, and Outcomes for Breast, Cervical, and Colorectal Cancer in the PROSPR Consortium. Barlow, WE., Beaber, EF., Geller, BM., et al.[2021]

Breast cancer screening through mammography has been shown to reduce breast cancer incidence by 25% and significantly lower mortality rates, according to randomized controlled trials and meta-analyses.

The article reviews various aspects of breast cancer screening, including methodologies, biases, benefits, and current guidelines, highlighting the importance of early detection for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mammography is the most effective method of breast cancer screening. Islam, SR., Aziz, SM.[2016]

Early diagnosis of cancer significantly reduces mortality rates and side effects, emphasizing the importance of recognizing non-specific symptoms and individual risk factors for timely detection.

Organized cancer screening programs are more effective than opportunistic screenings, as they allow for better quality control and evaluation, but both approaches must address potential issues like overdiagnosis and socio-economic inequalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Screening and early diagnosis of cancers: 2 ways for a same goal]. Bourmaud, A., Nourissat, A., Chauvin, F.[2010]

The study developed an automated algorithmic pipeline that efficiently identifies patients eligible for precision medicine clinical trials based on genetic biomarkers, addressing the time-consuming and inconsistent manual processes currently used by healthcare providers.

This algorithm was successfully applied to patients at the Stanford Cancer Center, demonstrating its feasibility and accuracy as an effective alternative to traditional methods of clinical trial curation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Clinical Trial Accrual via Automated Matching of Biomarker Criteria. Chen, JW., Kunder, CA., Bui, N., et al.[2022]

Cancer screening aims to detect cancer early in asymptomatic individuals to reduce mortality rates, requiring a solid understanding of cancer biology and effective interventions.

Currently, the Pap test for cervical cancer and mammography for breast cancer are the most effective screening methods available for women, showing significant potential in controlling these prevalent cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening: potential for cancer prevention. Newell, GR.[2005]

Cancer screening programs are essential for early detection of cancerous lesions, but they must be carefully evaluated for their benefits, risks, and limitations to avoid exposing healthy individuals to unnecessary risks.

In France, a major reorganization of cancer screening programs is underway to create a regional network that ensures equitable access and quality implementation, guided by established criteria for screening efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cancer screening: for who? Why? How? What organizational evolution?] de Bels, F.[2019]

The breast cancer screening system was successfully installed in just five days and operated reliably without major breakdowns, demonstrating its efficiency for clinical use.

The system allows for rapid evaluation of mammography exams, processing up to 100 exams per hour, and effectively supports the workflow of the German Mammography Screening program, ensuring timely and accurate assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Teleradiology and mammography screening: evaluation of a network with dedicated workstations for reporting]. Fröhlich, CP., Weigel, C., Mohr, M., et al.[2019]

The French national breast cancer screening program, which offers biennial mammograms to women aged 50-74, has a participation rate of 52.7% and has contributed to a decline in breast cancer mortality, although the specific impact of screening is difficult to measure due to other factors like improved treatments.

Over-treatment remains a significant concern, with estimates of low-malignancy tumor detection ranging from 1% to 30%, highlighting the need to refine the screening program to focus on higher-risk populations and improve the quality of mammography readings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Organized breast cancer screening]. Rouëssé, J., Sancho-Garnier, H.[2015]

Citations