Clinical trial · Observational
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments
NCT04056247CI-TRIAL-00096598PROPHETICactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IIIb-d Malignant Melanoma | — | UNRESOLVED | — |
| Stage III Unresectable Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Malignant Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma sample collection | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Stage IV NSCLC patients
- description
- 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.
- interventionNames
- Other: Plasma sample collection
- label
- Stage III unresectable NSCLC patients
- description
- Patients with Stage III unresectable NSCLC treated with ICI therapy or ICI in combination with chemotherapy
- interventionNames
- Other: Plasma sample collection
- label
- Stage IV malignant melanoma patients
- description
- 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).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDShaked 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 27118493
- BACKGROUNDShaked 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 17671170
- BACKGROUNDShaked 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 16305351
- DERIVEDChristopoulos 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 38513170