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临床试验/CTRI/2024/01/061792
CTRI/2024/01/061792尚未招募不适用

MOLECULAR PROFILING OF MICRORNAS AS BIOMARKERS IN BREAST CANCER-INTEGRATED OMICS ANALYSIS IN TERTIARY CARE HOSPITAL

Government Mohan Kumaramangalam Medical College1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
1. Diagnostic microRNA in breast cancer patients versus healthy adults such as miR-16, miR-19b, miR-106a, miR-21, miR-1246, miR-939, miR-373, miR-101, miR155, let-7 family of miR125b, miR100, miR34a, miR-335

研究概览

简要总结

Breastcancer (BC) is the most common cancer among women, with approximately 2.3 millionnew cases and over 685,000 deaths worldwide in 2020. India is no exception.Risk factors include age, genetics, and lifestyle choices. Challenges in Indiainclude relatively younger age of onset, late-stage diagnosis, limited accessto quality healthcare in rural areas, and lack of awareness about symptoms andrisk factors. Treatment options include surgery, chemotherapy, radiation, andhormonal therapies. Research on early detection and effective targetedtherapies is the need of the hour to improve overall and disease-free survivalrates.

MicroRNA(miR) profiling is a valuable tool in breast cancer research and clinicalpractice to analyse the expression levels of microRNAs (miRNAs) in breastcancer tissue. The role of miR profiling in breast cancer includes thefollowing:

1.       Biomarker Discovery: MicroRNAprofiling helps identify specific miRNAs that are either overexpressed orunderexpressed in breast cancer tissue. These miRNAs can serve as potentialbiomarkers for diagnosis, prognosis, and predicting treatment responses.

2.       Molecular Subtyping: MicroRNAprofiles can aid in classifying breast cancer into different molecularsubtypes, such as luminal, HER2-enriched, and triple-negative. Thisclassification is crucial for tailoring treatment strategies to the uniquecharacteristics of the tumour.

3.       Prognostication: Certain miRNAexpression patterns are associated with different outcomes in breast cancerpatients. High or low expression of specific miRNAs can indicate a better orworse prognosis, assisting healthcare professionals in making informedtreatment decisions.

4.       Identification of Therapeutic Targets:MicroRNA profiling can reveal miRNAs that play a significant role in cancerprogression, metastasis, and drug resistance. Targeting these miRNAs withtherapeutic interventions or drugs may offer new avenues for breast cancertreatment.

5.       Personalized therapies: Byanalysing a patient’s microRNA profile, personalized treatment strategiestargeting the unique genetic characteristics of a patient’s breast cancer arepossible, potentially leading to improved survival.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 1.Consecutive patients with newly detected breast cancer- planned for surgery (MRM or BCT) or Neo-adjuvant chemotherapy 2.Age and sex-matched subjects without breast cancer.

排除标准

  • 1.Known case of Breast cancer previously treated with surgery, chemotherapy or radiotherapy 2.Previous history of treatment for non-breast cancer 3.Patients with unsound mind 4.Patients not willing.

结局指标

主要结局

1. Diagnostic microRNA in breast cancer patients versus healthy adults such as miR-16, miR-19b, miR-106a, miR-21, miR-1246, miR-939, miR-373, miR-101, miR155, let-7 family of miR125b, miR100, miR34a, miR-335

时间窗: 1. Early Breast Cancer | Before Surgery | Before Adjuvant Chemotherapy | Before Adjuvant Radiotherapy | 3-month post-chemoradiotherapy | 2.Locally Advanced Breast cancer | Before neoadjuvant therapy | Before Surgery | Before Adjuvant Chemotherapy | Before Adjuvant Radiotherapy | 3-month post-CRT | 3. Metastatic Breast Cancer | Before and after palliative therapy

2. Prognostic microRNA in Breast Cancer such as miR-16, miR-19b, miR-106a, miR-21, miR-1246, miR-939, miR-373, miR-101, miR155, let-7 family of miR125b, miR100, miR34a, miR-335

时间窗: 1. Early Breast Cancer | Before Surgery | Before Adjuvant Chemotherapy | Before Adjuvant Radiotherapy | 3-month post-chemoradiotherapy | 2.Locally Advanced Breast cancer | Before neoadjuvant therapy | Before Surgery | Before Adjuvant Chemotherapy | Before Adjuvant Radiotherapy | 3-month post-CRT | 3. Metastatic Breast Cancer | Before and after palliative therapy

次要结局

  • microRNA (miR) profile- Early BC markers-miR-16 and miR-106a, a miR-19b-based 3-circulating miRNA(miR profile - Invasive Breast Cancer-miR-12, miR-1246)

研究者

发起方
Government Mohan Kumaramangalam Medical College
申办方类型
Government medical college

研究点 (1)

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