15000 Participants Needed

Screening Platform for Cancer Eligibility

Recruiting at 174 trial locations
RS
Overseen ByReference Study ID Number: BX43361 https://forpatients.roche.com
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.

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 data supports the effectiveness of the Screening platform treatment for cancer?

The effectiveness of cancer screening is supported by research showing that organized screening programs can reduce cancer-related deaths by identifying diseases early. For example, mammography screening for breast cancer has been shown to reduce mortality by 25%.12345

Is the cancer screening platform generally safe for humans?

The research highlights that cancer screening programs can have negative impacts such as false-positive results and overdiagnosis, which can affect a person's life. It is important to evaluate the benefits and risks of screening to ensure safety and effectiveness.16789

How is this cancer screening treatment different from other treatments?

This treatment is unique because it focuses on screening healthy individuals to detect cancer early, which can lead to better outcomes by identifying the disease before symptoms appear. Unlike other treatments that target existing cancer, this approach aims to prevent cancer progression by catching it early through organized and systematic screening programs.110111213

Research Team

CT

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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
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Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Non-Small Cell Lung Cancer (NSCLC)Experimental Treatment1 Intervention
Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.

Find a Clinic Near You

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 profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Findings from Research

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.
Principles of successful cancer screening.Smith, RA.[2016]
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.
Increasing Clinical Trial Accrual via Automated Matching of Biomarker Criteria.Chen, JW., Kunder, CA., Bui, N., et al.[2022]
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.
Conceptual Model for the Hepatocellular Carcinoma Screening Continuum: Current Status and Research Agenda.Singal, AG., Lok, AS., Feng, Z., et al.[2023]

References

Principles of successful cancer screening. [2016]
Increasing Clinical Trial Accrual via Automated Matching of Biomarker Criteria. [2022]
Conceptual Model for the Hepatocellular Carcinoma Screening Continuum: Current Status and Research Agenda. [2023]
Evaluating Screening Participation, Follow-up, and Outcomes for Breast, Cervical, and Colorectal Cancer in the PROSPR Consortium. [2021]
Mammography is the most effective method of breast cancer screening. [2016]
The balance sheet of benefits and harms of breast cancer population-based screening in Europe: outcome research, practice and future challenges. [2015]
[Cancer screening: for who? Why? How? What organizational evolution?] [2019]
[Organized breast cancer screening]. [2015]
[Screening and early diagnosis of cancers: 2 ways for a same goal]. [2010]
[Teleradiology and mammography screening: evaluation of a network with dedicated workstations for reporting]. [2019]
SESy-Europe: a multi-language database dedicated to cancer screening monitoring. [2007]
12.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Aspects of providing the equipment for mass screening systems for the early detection of oncological diseases]. [2006]
Screening: potential for cancer prevention. [2005]