Survival Analysis in Patients with Advanced Solid Cancers with Low Serum Creatinine Referred to Specialist Palliative Care for Best Supportive Care at a Tertiary Cancer Hospital A Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Primary outcome of this study is Overall survival (OS) defined as the time period between the date of recruitment to the date of death from any cause. To assess the impact of serum creatinine levels (less than 0.6mg/dL) on the frequency of disease progression in cancer patients not on any disease-directed treatment.
研究概览
简要总结
This study is a prospective observational investigation focused on evaluating overall survival (OS) in patients with advanced solid cancers and low serum creatinine (S.Cr) levels who are referred for palliative care. Conducted at Tata Memorial Hospital and Advanced Centre for Treatment, Research and Education in Cancer (ACTREC) the study aims to analyze survival trends and their correlation with low S.Cr levels in the absence of cancer-directed treatments.
Key Points:
- Aim: To determine survival outcomes in advanced cancer patients with low S.Cr levels (<0.6 mg/dL).
- Primary Outcome: OS, defined as the time from recruitment to death due to any cause. Patients will be followed until death or one year from the recruitment of the last patient.
- Secondary Outcomes: Median survival and the effect of serum albumin levels on survival.
- Sample Size: 120 patients, with a 20% attrition rate considered.
- Methodology: Patients are categorized into two groups based on S.Cr levels (<0.4 mg/dL and 0.4-0.6 mg/dL). Follow-ups are conducted every four weeks via medical records or telephone.
- Statistical Analysis: Kaplan-Meier for survival analysis, and Cox proportional hazards for multivariate analysis.
- Significance: The study findings will enhance prognostic capabilities and inform palliative care decisions.
No invasive procedures are involved, ensuring minimal risks, while all participants receive standard palliative care.
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
- •18 years of age or older
- •Diagnosed case of advanced solid cancers havingserum creatinine less than 0.6mg/dLand serum albumin reportswithin last 4 weeks of the visit.
- •Not planned for any disease-directed treatment.
- •Able to sign informed consent.
排除标准
- •Not willing to participate in the study
- •Pregnant or breastfeeding patients.
- •Hematological malignancies.
- •Patients with recent laboratory values not available.
结局指标
主要结局
Primary outcome of this study is Overall survival (OS) defined as the time period between the date of recruitment to the date of death from any cause. To assess the impact of serum creatinine levels (less than 0.6mg/dL) on the frequency of disease progression in cancer patients not on any disease-directed treatment.
时间窗: These patients will be followed up every 4 weeks till death or 12 months after recruitment of the last patient via details on the electronic medical record if the patient is visiting the hospital or telephonically to enquire about the general condition of the patient if no details are available on the electronic medical record.
次要结局
- The secondary outcome of this study is to assess impact on overall survival and median survival of patients not on any disease-directed treatment with serum creatinine of 0.4-0.6mg/dL.
研究者
Dr Raghu Thota
Tata Memorial Hospital