NCT04056247

Brief Summary

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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
42mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
5 countries

41 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Oct 2019Oct 2029

First Submitted

Initial submission to the registry

August 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2029

Last Updated

October 15, 2025

Status Verified

July 1, 2025

Enrollment Period

10 years

First QC Date

August 11, 2019

Last Update Submit

October 12, 2025

Conditions

Stage IV Non-small Cell Lung CancerStage IV Malignant MelanomaStage IV Small Cell Lung CancerStage III Unresectable Non-Small Cell Lung CancerStage IIIb-d Malignant Melanoma

Keywords

Non-small Cell Lung CancerSmall Cell Lung CancerMalignant Melanoma

Outcome Measures

Primary Outcomes (4)

  • Measured biological features at baseline (pre-treatment) and after 1st dose administration (on-treatment) and during treatment (optional)

    Biological features are analyzed in biological samples taken from the patients as part of the study

    Measured biological features are analyzed in samples taken at baseline (prior treatment) and after the 1st dose administration (on-treatment) and during treatment (optional)

  • Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care

    Overall response as determined by RECIST 1.1 or any other validated clinical scales for response, every 3 months or according to the standard of care

    Every 3 months or according to the standard of care

  • Progression Free Survival (PFS)

    Collect Progression Free Survival (PFS) dates

    At progression during treatment

  • Overall survival or last follow-up

    Collect overall survival or last follow-up dates

    Overall survival or last follow-up

Secondary Outcomes (1)

  • Adverse Events (AE)

    Adverse events (AE) during treatment and until the end of study

Study Arms (5)

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.

Other: Plasma sample collection

Stage III unresectable NSCLC patients

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

Other: Plasma sample collection

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).

Other: Plasma sample collection

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.

Other: Plasma sample collection

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.

Other: Plasma sample collection

Interventions

Plasma sample collectionOTHER

Collect at least two plasma samples

Stage III unresectable NSCLC patientsStage IIIb-d malignant melanoma patientsStage IV NSCLC patientsStage IV SCLC patientsStage IV malignant melanoma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. 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. 2. Stage III unresectable NSCLC patients treated with ICI therapy or ICI in combination with chemotherapy. 3. 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). 4. 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. 5. Stage IV SCLC patients treated with any regimen of ICI, chemotherapy or combination of ICI and chemotherapy in any line of treatment.

You may qualify if:

  • 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:
  • Absolute neutrophil count higher than 1500/mm3
  • Platelets count higher than 100,000/mm3
  • haemoglobin higher than 9 g/dL
  • Creatinine concentration ≤1.4 mg/dL, or creatinine clearance higher than 40 mL/min
  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (41)

Birmingham VAHCS

Birmingham, Alabama, 35233, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Florida Cancer Specialist and Research Institute

Orlando, Florida, 32827, United States

Location

Protean Biodiagnosics

Orlando, Florida, 32827, United States

Location

Northwest Community Healthcare

Rolling Meadows, Illinois, 60008, United States

Location

Helen Nassif Community Cancer Center

Cedar Rapids, Iowa, 52403, United States

Location

Rutgers Cancer Institute

New Brunswick, New Jersey, 08903, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

West Clinic

Germantown, Tennessee, 38138, United States

Location

Michael E. Debakey VA Medical Center

Houston, Texas, 77030, United States

Location

151-Christus Health St. Michael

Texarkana, Texas, 75503, United States

Location

Asklepois

Gauting, 82131, Germany

Location

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

Haemek Medical Center

Afula, Israel

Location

Barzilai Medical Center

Ashkelon, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Shamir Medical Center

Be’er Ya‘aqov, Israel

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Hadassah Medcial Center

Jerusalem, Israel

Location

Meir medical center

Kfar Saba, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Kaplan Medical Center

Rehovot, Israel

Location

Assuta Medical Cetner

Tel Aviv, Israel

Location

Sheba Medical Center

Tel Aviv, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

Sheba medical center

Tel Litwinsky, Israel

Location

044 Hospital Universitario Virgen Macarena

Seville, Spain

Location

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

Royal Bournemouth General Hospital

Bournemouth, United Kingdom

Location

Bradford Teaching Hospitals

Bradford, BD9 6RJ, United Kingdom

Location

Cheltenham General Hospital

Cheltenham, United Kingdom

Location

Withybush Hospital

Haverfordwest, SA61 2PZ, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, United Kingdom

Location

The Shrewsbury and Telford Hospital

Shrewsbury, United Kingdom

Location

South Tyneside

South Shields, NE34 0PL, United Kingdom

Location

Lister Hospital

Stevenage, United Kingdom

Location

Sunderland Royal Hospital

Sunderland, SR4 7TP, United Kingdom

Location

Swansea Bay UHB Singleton Hospital

Swansea, United Kingdom

Location

Torbay Hospital

Torquay, United Kingdom

Location

Related Publications (4)

  • Shaked Y. Balancing efficacy of and host immune responses to cancer therapy: the yin and yang effects. Nat Rev Clin Oncol. 2016 Oct;13(10):611-26. doi: 10.1038/nrclinonc.2016.57. Epub 2016 Apr 26.

    PMID: 27118493BACKGROUND

  • Shaked Y, Kerbel RS. Antiangiogenic strategies on defense: on the possibility of blocking rebounds by the tumor vasculature after chemotherapy. Cancer Res. 2007 Aug 1;67(15):7055-8. doi: 10.1158/0008-5472.CAN-07-0905.

    PMID: 17671170BACKGROUND

  • Shaked Y, Bocci G, Munoz R, Man S, Ebos JM, Hicklin DJ, Bertolini F, D'Amato R, Kerbel RS. Cellular and molecular surrogate markers to monitor targeted and non-targeted antiangiogenic drug activity and determine optimal biologic dose. Curr Cancer Drug Targets. 2005 Nov;5(7):551-9. doi: 10.2174/156800905774574020.

    PMID: 16305351BACKGROUND

  • Christopoulos P, Harel M, McGregor K, Brody Y, Puzanov I, Bar J, Elon Y, Sela I, Yellin B, Lahav C, Raveh S, Reiner-Benaim A, Reinmuth N, Nechushtan H, Farrugia D, Bustinza-Linares E, Lou Y, Leibowitz R, Kamer I, Zer Kuch A, Moskovitz M, Levy-Barda A, Koch I, Lotem M, Katzenelson R, Agbarya A, Price G, Cheley H, Abu-Amna M, Geldart T, Gottfried M, Tepper E, Polychronis A, Wolf I, Dicker AP, Carbone DP, Gandara DR. Plasma Proteome-Based Test for First-Line Treatment Selection in Metastatic Non-Small Cell Lung Cancer. JCO Precis Oncol. 2024 Mar;8:e2300555. doi: 10.1200/PO.23.00555.

    PMID: 38513170DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma samples.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungMelanomaSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alona Zer, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

  • Michal Lotem, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

  • Jair Bar, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Maya Gottfried, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

  • Abed Agbaria, MD

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

  • Ido Wolf, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Mahmud Abu-Amana, MD

    haemek medical center

    PRINCIPAL INVESTIGATOR

  • Rivka Katsenelson, MD

    Kaplan Medical Center

    PRINCIPAL INVESTIGATOR

  • Alexander Yakobson, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

  • Tatiana Harkovsky, MD

    Barzilai Medical Center

    PRINCIPAL INVESTIGATOR

  • Mor Moskovitz, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

  • Elizabeta Dudnik, MD

    Assuta Medical Center

    PRINCIPAL INVESTIGATOR

  • Raya Leibowitz, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

  • Adam Berger, MD

    Rutgers Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Jose Lutzky, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

  • Antony Magliocco, MD

    Protean BioDiagnostics

    PRINCIPAL INVESTIGATOR

  • Gillian Price, MD

    Aberdeen Royal Infirmary

    PRINCIPAL INVESTIGATOR

  • Helen Cheley

    Swansea Bay UHB - Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Louise Medley, MD

    Torbay and South Devon NHS foundation

    PRINCIPAL INVESTIGATOR

  • Tom Geldart, MD

    Royal Bournemouth General Hospital Dorset

    PRINCIPAL INVESTIGATOR

  • Anirban Chatterjee, MD

    The Shrewsbury and Telford Hospital

    PRINCIPAL INVESTIGATOR

  • Sean Brown, MD

    Gloucestershire Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

  • Andreas Polychronis, MD

    Mount Vernon Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Andreas Polychronis, MD

    Lister Hospital

    PRINCIPAL INVESTIGATOR

  • Ari VanderWalde, MD

    West Clinic

    PRINCIPAL INVESTIGATOR

  • Davika Das, MD

    VAHCS Birmingham

    PRINCIPAL INVESTIGATOR

  • Alison Brewster, MD

    Withybush Hospital Hawl Dda University Health Board

    PRINCIPAL INVESTIGATOR

  • Adam Hassani

    Sunderland Royal Hospital

    PRINCIPAL INVESTIGATOR

  • Adam Hassani, MD

    South Tyneside District

    PRINCIPAL INVESTIGATOR

  • Andrew Conn, MD

    Bradford Teaching Hospitals

    PRINCIPAL INVESTIGATOR

  • Yanyan Lou, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Igor Puzanov, MD

    Roswell Park

    PRINCIPAL INVESTIGATOR

  • Ernesto Bustinza, MD

    Florida Cancer Specialists and Research Institute

    PRINCIPAL INVESTIGATOR

  • Huang Quillan, MD

    Michael E. DeBakey VA Medical Center

    PRINCIPAL INVESTIGATOR

  • Ronnie Shapira Frommer, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Astrid Ammendola, MD

    Asklepios Klinik Gauting GmbH

    PRINCIPAL INVESTIGATOR

  • Petros Christopoulos, MD

    Thoraxklinik-Heidelberg gGmbH

    PRINCIPAL INVESTIGATOR

  • Marina Messinger, MD

    Northwest Community Healthcare

    PRINCIPAL INVESTIGATOR

  • Sunil Patel, MD

    CHRISTUS St. Michael Health System

    PRINCIPAL INVESTIGATOR

  • Bharat P Jenigiri, MD

    Physicians Clinic of Iowa

    PRINCIPAL INVESTIGATOR

  • David Vecente, MD

    Hospital Universitario Virgen Macarena

    PRINCIPAL INVESTIGATOR

  • Eugenie Younger, MD

    Gloucestershire Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2019

First Posted

August 14, 2019

Study Start

October 1, 2019

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

October 1, 2029

Last Updated

October 15, 2025

Record last verified: 2025-07

Locations

IL(14)DE(2)GB(12)US(12)ES(1)