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Clinical Trial Finder

Search Results

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

Study Purpose

The PROPHETIC study is a prospective, multi-center, international clinical study aimed at developing an algorithm to predict patient outcomes. The study involves analyzing the proteomic profiles of patients undergoing therapy to assess the likelihood of clinical benefit from their prescribed treatment. Blood samples are collected prior to and during the treatment period and analyzed as part of the ongoing development of thealgorithm.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria.

  • - Provision of informed consent prior to any study-specific procedures.
  • - Male or female aged at least 18 years.
  • - 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.
  • - At least one measurable lesion in order to enable the assessment of the response (except for stage IIIb-d malignant melanoma patients).

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04056247
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

OncoHost Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Alona Zer, MDMichal Lotem, MDJair Bar, MDMaya Gottfried, MDAbed Agbaria, MDIdo Wolf, MDMahmud Abu-Amana, MDRivka Katsenelson, MDAlexander Yakobson, MDTatiana Harkovsky, MDMor Moskovitz, MDElizabeta Dudnik, MDRaya Leibowitz, MDAdam Berger, MDJose Lutzky, MDAntony Magliocco, MDGillian Price, MDHelen CheleyLouise Medley, MDTom Geldart, MDAnirban Chatterjee, MDSean Brown, MDAndreas Polychronis, MDAndreas Polychronis, MDAri VanderWalde, MDDavika Das, MDAlison Brewster, MDAdam HassaniAdam Hassani, MDAndrew Conn, MDYanyan Lou, MDIgor Puzanov, MDErnesto Bustinza, MDHuang Quillan, MDRonnie Shapira Frommer, MDAstrid Ammendola, MDPetros Christopoulos, MDMarina Messinger, MDSunil Patel, MDBharat P Jenigiri, MDDavid Vecente, MDEugenie Younger, MD
Principal Investigator Affiliation Rambam Health Care CampusHadassah Medical OrganizationSheba Medical CenterMeir Medical CenterBnai Zion Medical CenterTel-Aviv Sourasky Medical Centerhaemek medical centerKaplan Medical CenterSoroka University Medical CenterBarzilai Medical CenterRabin Medical CenterAssuta Medical CenterAssaf-Harofeh Medical CenterRutgers Cancer InstituteUniversity of MiamiProtean BioDiagnosticsAberdeen Royal InfirmarySwansea Bay UHB - Cancer InstituteTorbay and South Devon NHS foundationRoyal Bournemouth General Hospital DorsetThe Shrewsbury and Telford HospitalGloucestershire Hospitals NHS Foundation TrustMount Vernon Cancer CentreLister HospitalWest ClinicVAHCS BirminghamWithybush Hospital Hawl Dda University Health BoardSunderland Royal HospitalSouth Tyneside DistrictBradford Teaching HospitalsMayo ClinicRoswell ParkFlorida Cancer Specialists and Research InstituteMichael E. DeBakey VA Medical CenterSheba Medical CenterAsklepios Klinik Gauting GmbHThoraxklinik-Heidelberg gGmbHNorthwest Community HealthcareCHRISTUS St. Michael Health SystemPhysicians Clinic of IowaHospital Universitario Virgen MacarenaGloucestershire Hospitals NHS Foundation Trust
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Germany, Israel, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Stage IV Non-small Cell Lung Cancer, Stage IV Malignant Melanoma, Stage IV Small Cell Lung Cancer, Stage III Unresectable Non-Small Cell Lung Cancer, Stage IIIb-d Malignant Melanoma
Additional Details

The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records. In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.

Arms & Interventions

Arms

: Stage IV NSCLC patients

Stage IV NSCLC patients treated with ICI or a combination of ICI and chemotherapy in any line of treatment, or with chemotherapy as a first line treatment.

: Stage III unresectable NSCLC patients

Patients with Stage III unresectable NSCLC treated with ICI therapy or ICI in combination with chemotherapy

: Stage IV malignant melanoma patients

Stage IV malignant melanoma patients treated with any regimen that includes ICI therapy as a monotherapy or in combination with targeted therapy in any line of treatment. In specific sites, Stage IV melanoma patients treated with targeted therapy (as a reference population).

: Stage IIIb-d malignant melanoma patients

Stage IIIb-d malignant melanoma patients treated with any regimen that includes ICI therapy as monotherapy or in combination with targeted therapy as adjuvant therapy.

: Stage IV SCLC patients

Stage IV SCLC patients treated with any regimen of ICI, chemotherapy or combination of ICI and chemotherapy in any line of treatment.

Interventions

Other: - Plasma sample collection

Collect at least two plasma samples

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham VAHCS, Birmingham 4049979, Alabama 4829764

Status

Address

Birmingham VAHCS

Birmingham 4049979, Alabama 4829764, 35233

Mayo Clinic, Jacksonville 4160021, Florida 4155751

Status

Address

Mayo Clinic

Jacksonville 4160021, Florida 4155751, 32224

University of Miami, Miami 4164138, Florida 4155751

Status

Address

University of Miami

Miami 4164138, Florida 4155751, 33136

Orlando 4167147, Florida 4155751

Status

Address

Florida Cancer Specialist and Research Institute

Orlando 4167147, Florida 4155751, 32827

Protean Biodiagnosics, Orlando 4167147, Florida 4155751

Status

Address

Protean Biodiagnosics

Orlando 4167147, Florida 4155751, 32827

Northwest Community Healthcare, Rolling Meadows 4908052, Illinois 4896861

Status

Address

Northwest Community Healthcare

Rolling Meadows 4908052, Illinois 4896861, 60008

Helen Nassif Community Cancer Center, Cedar Rapids 4850751, Iowa 4862182

Status

Address

Helen Nassif Community Cancer Center

Cedar Rapids 4850751, Iowa 4862182, 52403

Rutgers Cancer Institute, New Brunswick 5101717, New Jersey 5101760

Status

Address

Rutgers Cancer Institute

New Brunswick 5101717, New Jersey 5101760, 08903

Roswell Park, Buffalo 5110629, New York 5128638

Status

Address

Roswell Park

Buffalo 5110629, New York 5128638, 14263

West Clinic, Germantown 4624601, Tennessee 4662168

Status

Address

West Clinic

Germantown 4624601, Tennessee 4662168, 38138

Michael E. Debakey VA Medical Center, Houston 4699066, Texas 4736286

Status

Address

Michael E. Debakey VA Medical Center

Houston 4699066, Texas 4736286, 77030

151-Christus Health St. Michael, Texarkana 4736096, Texas 4736286

Status

Address

151-Christus Health St. Michael

Texarkana 4736096, Texas 4736286, 75503

International Sites

Asklepois, Gauting 2922230, Germany

Status

Address

Asklepois

Gauting 2922230, , 82131

Thoraxklinik Heidelberg gGmbH, Heidelberg 2907911, Germany

Status

Address

Thoraxklinik Heidelberg gGmbH

Heidelberg 2907911, , 69126

Haemek Medical Center, Afula 295740, Israel

Status

Address

Haemek Medical Center

Afula 295740, ,

Barzilai Medical Center, Ashkelon 295620, Israel

Status

Address

Barzilai Medical Center

Ashkelon 295620, ,

Soroka Medical Center, Beersheba 295530, Israel

Status

Address

Soroka Medical Center

Beersheba 295530, ,

Shamir Medical Center, Be’er Ya‘aqov 295525, Israel

Status

Address

Shamir Medical Center

Be’er Ya‘aqov 295525, ,

Bnai Zion Medical Center, Haifa 294801, Israel

Status

Address

Bnai Zion Medical Center

Haifa 294801, ,

Rambam Medical Center, Haifa 294801, Israel

Status

Address

Rambam Medical Center

Haifa 294801, ,

Hadassah Medcial Center, Jerusalem 281184, Israel

Status

Address

Hadassah Medcial Center

Jerusalem 281184, ,

Meir medical center, Kfar Saba 294514, Israel

Status

Address

Meir medical center

Kfar Saba 294514, ,

Rabin Medical Center, Petah Tikva 293918, Israel

Status

Address

Rabin Medical Center

Petah Tikva 293918, ,

Kaplan Medical Center, Rehovot 293725, Israel

Status

Address

Kaplan Medical Center

Rehovot 293725, ,

Assuta Medical Cetner, Tel Aviv 293397, Israel

Status

Address

Assuta Medical Cetner

Tel Aviv 293397, ,

Sheba Medical Center, Tel Aviv 293397, Israel

Status

Address

Sheba Medical Center

Tel Aviv 293397, ,

Sourasky Medical Center, Tel Aviv 293397, Israel

Status

Address

Sourasky Medical Center

Tel Aviv 293397, ,

Sheba medical center, Tel Litwinsky 293361, Israel

Status

Address

Sheba medical center

Tel Litwinsky 293361, ,

Seville 2510911, Spain

Status

Address

044 Hospital Universitario Virgen Macarena

Seville 2510911, ,

Aberdeen Royal Infirmary, Aberdeen 2657832, United Kingdom

Status

Address

Aberdeen Royal Infirmary

Aberdeen 2657832, ,

Royal Bournemouth General Hospital, Bournemouth 2655095, United Kingdom

Status

Address

Royal Bournemouth General Hospital

Bournemouth 2655095, ,

Bradford Teaching Hospitals, Bradford 2654993, United Kingdom

Status

Address

Bradford Teaching Hospitals

Bradford 2654993, , BD9 6RJ

Cheltenham General Hospital, Cheltenham 2653261, United Kingdom

Status

Address

Cheltenham General Hospital

Cheltenham 2653261, ,

Withybush Hospital, Haverfordwest 2647311, United Kingdom

Status

Address

Withybush Hospital

Haverfordwest 2647311, , SA61 2PZ

Mount Vernon Cancer Centre, Northwood 2641216, United Kingdom

Status

Address

Mount Vernon Cancer Centre

Northwood 2641216, ,

The Shrewsbury and Telford Hospital, Shrewsbury 2637891, United Kingdom

Status

Address

The Shrewsbury and Telford Hospital

Shrewsbury 2637891, ,

South Tyneside, South Shields 2637329, United Kingdom

Status

Address

South Tyneside

South Shields 2637329, , NE34 0PL

Lister Hospital, Stevenage 2636940, United Kingdom

Status

Address

Lister Hospital

Stevenage 2636940, ,

Sunderland Royal Hospital, Sunderland 2636531, United Kingdom

Status

Address

Sunderland Royal Hospital

Sunderland 2636531, , SR4 7TP

Swansea Bay UHB Singleton Hospital, Swansea 2636432, United Kingdom

Status

Address

Swansea Bay UHB Singleton Hospital

Swansea 2636432, ,

Torbay Hospital, Torquay 2635650, United Kingdom

Status

Address

Torbay Hospital

Torquay 2635650, ,

Resources

  • Patient and Caregiver Survey
  • Clinical Trial Endpoints
  • Research Resources
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The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.

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