Clinicopathological Characteristics of Cancer Patients Undergoing Mismatch Repair Gene Testing in a Tertiary Cancer Center in Kerala, India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- To determine the prevalence of MSI testing and its outcomes in solid tumours in a tertiary care centre
研究概览
简要总结
Abstract
Title: Clinicopathological Characteristics of Cancer Patients Undergoing Mismatch Repair Gene Testing in a Tertiary Cancer Center in Kerala, India
Background: DNA damage from various sources can lead to mutations, driving diseases like cancer. The DNA mismatch repair (MMR) pathway is crucial for maintaining genomic integrity by preventing such mutations. MMR deficiency (dMMR) is associated with hereditary cancer syndromes and several sporadic cancers, including colorectal and endometrial cancers. Testing for MMR status via immunohistochemistry (IHC) is common and aids in diagnosing hereditary cancers, guiding therapy, and predicting response to immune checkpoint inhibitors.
Objectives: This study aims to assess the clinicopathological characteristics and outcomes of cancer patients undergoing MMR testing at a tertiary cancer center in Kerala, India. The study will investigate demographic details, the frequency and distribution of MMR deficiency, and correlations between MMR status and clinicopathological features.
Methods: This retrospective observational study will analyze data from January 1, 2018, to June 30, 2024, from the pathology and medical oncology departments of the Amala Institute of Medical Sciences, Thrissur. All cancer patients who underwent MMR testing within this period will be included, except pediatric patients and those with incomplete records. Data on demographics, cancer types, stages, tumor location, histological subtype, and MMR testing results will be extracted and analyzed using descriptive and analytical statistics. Chi-square tests, t-tests, ANOVA, and logistic regression will be employed to assess correlations and predictors of MMR deficiency.
Expected Outcomes: The study aims to enhance diagnostic criteria for MMR testing, optimize treatment strategies, improve clinical decision-making, and identify patterns in MMR-related cancers specific to the local context in Kerala. Insights from this study could contribute to better management of cancer patients with MMR deficiencies.
Ethical Considerations: Institutional ethics committee approval will be obtained, ensuring confidentiality and ethical handling of patient data. Waiver of consent is sought due to the retrospective nature of the study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age:All adult cancer patients aged 18 years and above.
- •MMR Testing: Patients who have undergone MMR testing using Immunohistochemistry (IHC) for MLH1, PMS2, MSH2, and MSH6 proteins.
- •Cancer Type: Patients diagnosed with any type of solid malignancy, including colorectal, endometrial, ovarian, and other cancers where MMR testing is clinically indicated.
- •Treatment History: Patients who have completed their primary cancer treatment (surgery, chemotherapy, radiation) and for whom MMR testing was part of the diagnostic or therapeutic decision-making process.
- •Clinical Data Availability: Patients with complete clinical records, including demographic data, tumor characteristics, treatment details, and MMR test results.
- •Follow-up Data: Patients with documented follow-up data to assess treatment outcomes, response to therapy, and survival.
排除标准
- •Pediatric Patients: Patients younger than 18 years of age.
- •Incomplete Records: Patients with incomplete clinical records, particularly those missing MMR test results or key demographic and tumor-related information.
- •Non-Solid Tumors: Patients with hematological malignancies or other non-solid tumors that do not typically undergo MMR testing.
- •No Follow-up Data: Patients with no available follow-up data, making it impossible to assess treatment outcomes and survival.
结局指标
主要结局
To determine the prevalence of MSI testing and its outcomes in solid tumours in a tertiary care centre
时间窗: 0,6,9 months
次要结局
- Analyze the demographic details of cancer patients on whom Mismatch Repair Gene Testing (MMR) was done at a tertiary cancer center in India.
- Assess the frequency and distribution of MMR deficiency among cancer patients in the study population.
- Identify any correlations between MMR status and clinicopathological features, such as age, gender, tumor location, and histological subtype.
研究者
Dr Navya Mathew
Amala Institute of Medical Sciences