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临床试验/NCT07484971
NCT07484971招募中不适用

Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria

Société Algérienne de Formation et Recherche en Oncologie24 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2025年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,000
试验地点
24
主要终点
Socio-demographic characteristics of patients with prostate cancer in Algeria

研究概览

简要总结

The goal of this observational study is to describe the demographic, epidemiological, clinical, and outcome characteristics of patients with prostate cancer.

It also aims to analyze the diagnostic approaches and management strategies used in the care of these patients in Algeria.

详细描述

This is a descriptive, cross-sectional clinical study including patients with histologically and/or biologically confirmed prostate cancer who are being followed in the participating centers. This study planned to enroll 500 patients.

Data will be collected from medical records and structured patient interviews (≈30 minutes). A standardized electronic case report form (eCRF) will be used to ensure completeness and reliability of the data. The variables studied will include sociodemographic data, medical history, clinical and biological characteristics of the disease, diagnostic examinations performed, and the therapeutic strategies implemented. All information will be anonymized and used exclusively for research purposes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients aged 19 years and older.
  • Diagnosis of prostate cancer confirmed histologically and/or biologically.
  • Patients followed in the participating oncology departments.
  • Written informed consent obtained.
  • Non Inclusion Criteria:
  • Histological types other than carcinoma
  • Secondary tumors
  • Participation in an interventional study

排除标准

  • 未提供

结局指标

主要结局

Socio-demographic characteristics of patients with prostate cancer in Algeria

时间窗: At Baseline ( Initial visit )

Frequency (%) of sociodemographic characteristics of patients with prostate cancer in Algeria, including age at diagnosis, marital status, and socioeconomic level.

Personal and family history of cancer

时间窗: At Baseline (Initial Visit)

Frequency (%) of patients with personal and family history of cancer.

Environmental and occupational exposures

时间窗: At Baseline (Initial visit)

Frequency (%) of patients with environmental or occupational exposures.

Smoking history

时间窗: At Baseline (Initial visit)

Frequency (%) of patients according to smoking status (current, former, never).

Alcohol consumption

时间窗: At Baseline (Initial visit)

Frequency (%) of patients according to alcohol consumption (yes/no).

Initial symptoms and circumstances of diagnosis

时间窗: At Baseline (Initial visit)

Frequency (%) of patients according to type of initial symptoms and circumstances of diagnosis.

International Prostate Symptom Score (IPSS)

时间窗: At Baseline (Initial visit)

Distribution of patients according to the International Prostate Symptom Score (IPSS) at baseline. The IPSS is a validated questionnaire assessing the severity of lower urinary tract symptoms, with a total score ranging from 0 to 35, where higher scores indicate more severe (worse) symptoms.

Evolutionary status of patients

时间窗: At Baseline (Initial visit)

Frequency (%) of patients according to disease status (in remission or with disease progression).

次要结局

  • Diagnosis by PSA testing(At Baseline (Initial visit))
  • Diagnosis by imaging(At Baseline (Initial visit))
  • Diagnosis by biopsy(At Baseline (Initial visit))
  • Time from symptom onset to first medical consultation(At Baseline (Initial visit))
  • Time from first consultation to confirmed diagnosis(At Baseline (Initial visit))
  • Patients discussed in multidisciplinary team meetings(At Baseline (Initial visit))
  • Initial treatment: Surgery(At Baseline (Initial visit))
  • Initial treatment: Radiotherapy(At Baseline (Initial visit))
  • Initial treatment: Hormone therapy(At Baseline (Initial visit))
  • Initial treatment: Active surveillance(At Baseline (Initial visit))
  • Time from diagnosis to treatment initiation(At Baseline (Initial visit))
  • Specialty of physician initiating treatment(At Baseline (Initial visit))
  • Adverse events(At Baseline (Initial visit))

研究者

发起方
Société Algérienne de Formation et Recherche en Oncologie
申办方类型
Other
责任方
Sponsor

研究点 (24)

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