Exploring Cancer-Associated Thromboembolism Prognosis Biomarkers and Polymorphisms
CAT_PB
Unveiling Prognosis Cancer-Associated Thromboembolism Biomarkers and Their Related Polymorphisms: Exploring Their Involvement With Immune Circulating Cells and Therapeutic Reversibility
1 other identifier
interventional
500
1 country
2
Brief Summary
This study aims to assess biomarkers and their related polymorphisms in the context of cancer-associated thromboembolism, with a particular focus on their interaction with the immune system. The roles of immune checkpoints, inflammatory and angiogenesis factors, as well as circulating immune cells will be elucidated. Additionally, our investigation extends to the exploration of long non-coding RNAs (LncRNAs) and genes associated with the coagulation vascular system. Initially, these aspects will be evaluated in the context of colorectal cancer, with the intention to expand our research to other solid tumors. The identification of these biomarkers and genetic factors holds the potential to revolutionize therapeutic approaches for patients with cancer-associated thromboembolism, shedding light on their chemotherapy resistance. The effectiveness of combining immunotherapy with targeted inhibitors like Palbociclib and anticoagulants such as Rivaroxaban, among other potential interventions, will be assessed. This study aims to make significant contributions to the understanding of these critical aspects, ultimately leading to the development of more effective treatment strategies for cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started Feb 2019
Longer than P75 for phase_1 cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 6, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 6, 2023
October 1, 2023
5.8 years
September 6, 2023
October 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Venous Thromboembolism (VTE) Events including: Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and other Thromboembolic Events (Vein Thrombosis, Portal Vein Thrombosis, Superior Mesenteric Vein Thrombosis, and Renal Vein Thrombosis)
The outcome measure of VTE including DVT, PE, and other thromboembolic events will be assessed by : (1) Clinical Assessment: Clinical symptoms such as swelling and pain in the lower limbs, tenderness behind the lower leg and/or medial thigh, and supplementary evaluation with color ultrasound of the veins in both lower limbs (lower extremity venography); (2) Imaging: CT pulmonary arteriography (CTPA) will be employed in conjunction with related clinical manifestations such as dyspnea and shortness of breath for diagnosing PE; (3) Laboratory Criteria: Diagnostic criteria will also consider laboratory parameters, including elevated D-dimer levels (\> 1000 ng/mL), increased fibrinogen levels (\> 700 mg/dL), and shortened activated partial thromboplastin time (aPTT) (\< 20 sec).
up to 60 months
Assessment of Cancer Progression
The assessment of cancer progression will be conducted using the standardized TNM staging system and applying the Response Evaluation Criteria (RECIST) guideline (ver. 1.1). Clinical parameters, laboratory tests indicative of cancer progression (including tumor markers and histopathological analysis), and relevant imaging modalities (e.g., CT, MRI, or PET scans) will be employed to evaluate the extent of primary tumor growth, lymph node involvement, and the presence of distant metastases. Progression-Free Survival (PFS), a key primary clinical endpoint for assessing cancer progression, will be calculated as the duration (in months) from the date of enrollment in the study until the tumor progresses, new lesions appear, or until the participant's death from any cause. Cancer progression will be determined based on RECIST guidelines, considering an increase in tumor size or the appearance of new lesions according to imaging assessments and clinical evaluations.
up to 60 months
Identification of Potential Biomarkers
The objective of this outcome is to identify and characterize novel biomarkers associated with thromboembolism and cancer progression. Specifically, the assessment will focus on Long Non-Coding RNAs (LncRNAs) such as CDKN2B and CDKN2B-AS1, and markers related to the vascular coagulation system including ACE, PAI-1, FXIII, and Prothrombin. This identification process will involve collecting biological samples (e.g., blood, tissue) from enrolled patients at the time of study enrollment. The assessment will analyze and evaluate the expression and polymorphisms of the studied genes (CDKN2B, CDKN2B-AS1, ACE, PAI-1, FXIII, and Prothrombin) using quantitative PCR (qPCR), with Ct (Cycle threshold) as the common unit of measure for all genes. This comprehensive assessment aims to enhance our understanding of the molecular signatures linked to thromboembolism and cancer progression, illuminating potential diagnostic and therapeutic avenues for improved patient outcomes.
Once at the moment of the patient's enrollment in the study
Evaluation of Treatment Response to Palbociclib
This primary outcome assesses treatment response in patients undergoing Palbociclib therapy for controlling cancer progression and thromboembolism. The evaluation will employ RECIST criteria to measure the percentage change in tumor size, indicative of treatment effectiveness.
up to 60 months
Secondary Outcomes (8)
Survival Rates
up to 60 months
Examination of Genetic Variants, specifically rs1333049 G>C Polymorphism within the CDKN2B-AS1 Gene
Once at the moment of the patient's enrollment in the study
Adverse Events
up to 60 months
Immunophenotyping of Immune Cell Populations
up to 60 months
Inflammatory Cytokine Profiling
up to 60 months
- +3 more secondary outcomes
Study Arms (5)
Non-Carriers of Targeted Gene-Related Polymorphisms (GRPs) in Cancer Patients
ACTIVE COMPARATORCancer patients without any incidence of thromboembolism will be included if they are non-carriers of the targeted gene-related polymorphism (GRP).
Carriers of Targeted GRPs in Cancer Patients
ACTIVE COMPARATORCancer patients without any incidence of thromboembolism will be included if they are carriers of the targeted gene-related polymorphism.
Carriers of Targeted GRPs in Cancer-Associated Thromboembolism Patients
EXPERIMENTALCancer patients with incidence of thromboembolism will be included if they are carriers of the targeted gene-related polymorphism.
Carriers of Targeted GRPs in Cancer-Associated Thromboembolism Patients Treated with Palbociclib
EXPERIMENTALCancer patients with incidence of thromboembolism will be included if they are carriers of the targeted gene-related polymorphism and will be subjected to Palbociclib treatment.
Carriers of Targeted GRPs in Cancer-Associated Thromboembolism Treated with Anti-Coagulant
EXPERIMENTALCancer patients with incidence of thromboembolism will be included if they are carriers of the targeted gene-related polymorphism and will be subjected to anti-coagulant treatment.
Interventions
Palbociclib will be administered at a dose of 125 mg oral on a 21/7 cycle.
Rivaroxaban will be administered at a dosage of 15 mg intravenously twice a day for 21 days, followed by 20 mg once daily for the subsequent 21 days.
diagnostics of patients' carriers or not of the risk allele(s)
Eligibility Criteria
You may qualify if:
- Individuals of white ethnicity.
- Age between \> 18
- Both males and females.
- Diagnosis of selected cancer type (e.g., colorectal cancer).
- Cancer stage 0/I/II without metastasis or lymph node dissemination at the time of enrollment.
- No previous cancer therapy (radiotherapy, chemotherapy, or immunotherapy) received before study enrollment.
- Unrelated patients.
You may not qualify if:
- Cancer stage III/IV.
- History of hematological cancer types or previous cancers, recurrent or relapse.
- Diagnosis of inflammatory bowel diseases.
- Pre-existing cardiovascular diseases or coronary artery diseases.
- Confirmed treated or untreated autoimmune diseases.
- Metabolic disorders, diabetes, or hypertension.
- Neurological diseases.
- Evidence of cardiac, renal, bone, or cerebral damage.
- Presence of more than one type of malignancies.
- Active infections or myositis.
- Familial polyposis.
- Alcohol or smoking habits.
- Colon-affecting food allergies.
- Body mass index (BMI) \>30.
- Significant weight loss within the last 2 years.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lebanese Universitylead
- Haykel Hospitalcollaborator
Study Sites (2)
Haykel Hospital
Tripoli, North Lebanon, 961, Lebanon
Lebanese University
Tripoli, North Lebanon, 961, Lebanon
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nehman Makdissy, Professor
Lebanese University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Professor
Study Record Dates
First Submitted
September 6, 2023
First Posted
October 4, 2023
Study Start
February 1, 2019
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
October 6, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share