Trial Title:
Exploring Cancer-Associated Thromboembolism Prognosis Biomarkers and Polymorphisms
NCT ID:
NCT06065592
Condition:
Cancer
Solid Tumor
Thromboembolism
Cardiovascular Diseases
Immune System Diseases
Inflammatory Diseases
Colon Cancer
Breast Cancer
Prostate Cancer
Hepatocellular Carcinoma
Lung Cancer
Chemotherapy
Immunotherapy
Conditions: Official terms:
Cardiovascular Diseases
Thromboembolism
Immune System Diseases
Palbociclib
Rivaroxaban
Conditions: Keywords:
cancer
thromboembolism
cardiovascular
immune cells
immunotherapy
chemotherapy
inflammation
gene polymorphism
biomarker
LncRNA
Palbociclib
Rivaroxaban
blood coagulation
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Single (Participant)
Intervention:
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
Palbociclib will be administered at a dose of 125 mg oral on a 21/7 cycle.
Arm group label:
Carriers of Targeted GRPs in Cancer-Associated Thromboembolism Patients Treated with Palbociclib
Other name:
Ibrance
Intervention type:
Drug
Intervention name:
Rivaroxaban
Description:
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.
Arm group label:
Carriers of Targeted GRPs in Cancer-Associated Thromboembolism Treated with Anti-Coagulant
Other name:
Xarelto
Intervention type:
Genetic
Intervention name:
SNP
Description:
diagnostics of patients' carriers or not of the risk allele(s)
Arm group label:
Carriers of Targeted GRPs in Cancer Patients
Arm group label:
Carriers of Targeted GRPs in Cancer-Associated Thromboembolism Patients
Arm group label:
Carriers of Targeted GRPs in Cancer-Associated Thromboembolism Patients Treated with Palbociclib
Arm group label:
Carriers of Targeted GRPs in Cancer-Associated Thromboembolism Treated with Anti-Coagulant
Arm group label:
Non-Carriers of Targeted Gene-Related Polymorphisms (GRPs) in Cancer Patients
Other name:
Risk Allele(s)
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.
Detailed description:
Cancer, especially solid tumors, remains a significant global health challenge despite
ongoing advancements in risk factor identification and targeted therapies. Among the
various complexities of cancer treatment, the relationship between cancer and
thromboembolism, characterized by arterial and venous thrombosis, has attracted attention
due to its significant impact on patient outcomes.
Cancer cells activate the coagulation system, leading to prothrombotic disorders in the
vascular wall and promoting tumor progression. Patients with cancer, particularly those
undergoing systemic chemotherapy, face an increased risk of thromboembolism due to
abnormal blood clotting mechanisms.
Recent research has emphasized the importance of identifying novel biomarkers for risk
assessment, prognosis determination, and treatment selection in cancer. Among these
biomarkers, long non-coding RNAs (LncRNAs) and those of the vascular coagulation system
have emerged as pivotal players in cancer development and progression. However, their
role as prognostic and predictive biomarkers for cancer risk and treatment response
remains relatively unexplored.
Understanding the complex interplay between cancer, immune responses, and thromboembolism
is crucial. Immunological subsets, including central immune effector T cells (CD8+,
CD25+), NK cells, and macrophages, have been linked to cancer prognosis. Furthermore,
therapies that modulate the immune system, such as immunotherapy and cell-based
therapies, hold promise for improving cancer treatment outcomes.
Most notably, these therapies exhibit immunomodulatory effects, triggering immunogenic
cell death and preventing immunosuppression. However, their efficacy may be compromised
in cases of cancer associated with clotting abnormalities within the circulatory system.
Progenitor cells, including stem cells and endothelial progenitor cells (EPCs), are
emerging as potential players in cancer therapy, offering new avenues for research.
Among the innovative approaches is the assessment of circulating immune and endothelial
progenitor cells (termed "CIEs"), which may play significant roles in the mechanisms
underlying cancer-associated thromboembolism. Understanding the relationship between
these cells, inflammatory and angiogenic factors, immune checkpoint, and cancer
progression could pave the way for improved cancer risk assessment and treatment
strategies.
This study seeks to contribute to our understanding of the intricate connections between
LncRNA, coagulation-related biomarkers, thromboembolism, immune responses, and cancer,
using solid tumors as a representative example. By shedding light on these complex
interactions, this study aims to identify potential biomarkers that can guide risk
assessment and treatment decisions, ultimately improving the management of cancer
patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- History of abdominal surgeries.
- Pregnancy.
- Related patients.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Haykel Hospital
Address:
City:
Tripoli
Zip:
961
Country:
Lebanon
Status:
Recruiting
Contact:
Last name:
Malak Naboulsi, MD
Phone:
+961228170
Email:
malak.naboulsi@gmail.com
Investigator:
Last name:
David Wehbe, MD
Email:
Sub-Investigator
Facility:
Name:
Lebanese University
Address:
City:
Tripoli
Zip:
961
Country:
Lebanon
Status:
Recruiting
Contact:
Last name:
Nehman Makdissy, Professor
Phone:
+96171210250
Email:
nehman.makdissy@ul.edu.lb
Investigator:
Last name:
Samar Hamoui, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Fida Ayoubi, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Noha Ibrahim, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Nadine Ghotme, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Christelle Rahme, MD, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Elisa Makdessi, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Bassam Bou Deleh, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Joelle Moustafa, MSc
Email:
Sub-Investigator
Investigator:
Last name:
Maria Mouawad, MSc
Email:
Sub-Investigator
Start date:
February 1, 2019
Completion date:
December 2024
Lead sponsor:
Agency:
Lebanese University
Agency class:
Other
Collaborator:
Agency:
Haykel Hospital
Agency class:
Other
Source:
Lebanese University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06065592
