Algorithm to predict treatment outcomes in advanced cancer patients
PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
This study is testing a new tool to help doctors predict how well standard treatments will work for patients with advanced lung cancer and melanoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | OncoHost Ltd. Industry-sponsored |
| Locations | 41 sites (Birmingham, Alabama and 40 other locations) |
| Trial ID | NCT04056247 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop an algorithm that predicts treatment outcomes for patients with stage IV non-small cell lung cancer (NSCLC) and malignant melanoma. Patients will receive standard cancer treatments while providing blood samples and clinical data, which will be used to create and validate the prediction algorithm. The study seeks to identify metabolic pathways that may lead to improved therapeutic options, ultimately assisting physicians in making informed treatment decisions.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with stage IV NSCLC or stage IV malignant melanoma who meet specific health criteria.
Not a fit: Patients with concurrent active malignancies or significant mental impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this algorithm could help tailor cancer treatments to individual patients, potentially improving their outcomes.
How similar studies have performed: Other studies have explored predictive algorithms in oncology, showing promise in improving treatment outcomes, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cancer patients with stage IV NSCLC or stage IV malignant melanoma * Patient must have at least one measurable lesion and the relevant images in order to enable assessment of response * ECOG PS - 0/1-2 * Normal hematologic, renal and liver function: 1. Absolute neutrophil count higher than 1500/mm3 2. Platelets count higher than 100,000/mm3 3. haemoglobin higher than 9 g/dL 4. Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min 5. Total bilirubin lower than 1.5 mg/dL, ALT and AST levels ≤ 3 times above the upper normal limit. Exclusion Criteria: * Concurrent and/or other active malignancy that has required systemic treatment within 2 years of first dose of study drug * Generalized impairment or mental incompetence that would render the patient unable to understand his/her participation in the study.
Where this trial is running
Birmingham, Alabama and 40 other locations
- Birmingham VAHCS — Birmingham, Alabama, United States (Recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Florida Cancer Specialist and Research Institute — Orlando, Florida, United States (Recruiting)
- Protean Biodiagnosics — Orlando, Florida, United States (Recruiting)
- Northwest Community Healthcare — Rolling Meadows, Illinois, United States (Recruiting)
- Helen Nassif Community Cancer Center — Cedar Rapids, Iowa, United States (Recruiting)
- Rutgers Cancer Institute — New Brunswick, New Jersey, United States (Recruiting)
- Roswell Park — Buffalo, New York, United States (Recruiting)
- West Clinic — Germantown, Tennessee, United States (Recruiting)
- Michael E. Debakey VA Medical Center — Houston, Texas, United States (Recruiting)
- 151-Christus Health St. Michael — Texarkana, Texas, United States (Recruiting)
- Asklepois — Gauting, Germany (Recruiting)
- Thoraxklinik Heidelberg gGmbH — Heidelberg, Germany (Recruiting)
- Haemek Medical Center — Afula, Israel (Recruiting)
- Barzilai Medical Center — Ashkelon, Israel (Recruiting)
- Soroka Medical Center — Be'er Sheva, Israel (Active_not_recruiting)
- Shamir Medical Center — Be'er Ya'aqov, Israel (Recruiting)
- Bnai Zion Medical Center — Haifa, Israel (Active_not_recruiting)
- Rambam Medical Center — Haifa, Israel (Recruiting)
- Hadassah Medcial Center — Jerusalem, Israel (Recruiting)
- Meir medical center — Kfar Saba, Israel (Recruiting)
- Rabin Medical Center — Petah tikva, Israel (Recruiting)
- Kaplan Medical Center — Reẖovot, Israel (Recruiting)
- Assuta Medical Cetner — Tel Aviv, Israel (Recruiting)
- Sheba Medical Center — Tel Aviv, Israel (Recruiting)
- Sourasky Medical Center — Tel Aviv, Israel (Completed)
- Sheba medical center — Tel HaShomer, Israel (Recruiting)
- 044 Hospital Universitario Virgen Macarena — Seville, Spain (Recruiting)
- Aberdeen Royal Infirmary — Aberdeen, United Kingdom (Recruiting)
- Royal Bournemouth General Hospital — Bournemouth, United Kingdom (Recruiting)
- Bradford Teaching Hospitals — Bradford, United Kingdom (Not_yet_recruiting)
- Cheltenham General Hospital — Cheltenham, United Kingdom (Recruiting)
- Withybush Hospital — Haverfordwest, United Kingdom (Recruiting)
- Mount Vernon Cancer Centre — Northwood, United Kingdom (Recruiting)
- The Shrewsbury and Telford Hospital — Shrewsbury, United Kingdom (Recruiting)
- South Tyneside — South Shields, United Kingdom (Recruiting)
- Lister Hospital — Stevenage, United Kingdom (Recruiting)
- Sunderland Royal Hospital — Sunderland, United Kingdom (Recruiting)
- Swansea Bay UHB Singleton Hospital — Swansea, United Kingdom (Recruiting)
- Torbay Hospital — Torquay, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Alona Zer, MD — 003 Rambam Medical Center
- Study coordinator: Shani Raveh Shoval, Ph.D.
- Email: shani@oncohost.com
- Phone: 97248537554
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.