- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484971
Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria (CLIQQC)
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.
Study Overview
Status
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: BOUNEDJAR ADDA, Professor
- Phone Number: +213 25 20 90 72
- Email: a_bounedjar@yahoo.fr
Study Locations
-
-
Algeria
-
Adrar, Algeria, Algeria, 01000
- Not yet recruiting
- CAC Adrar - Oncology Department
-
Contact:
- KOUIDER KHADIDJA, Professor
- Phone Number: +213 49 36 89 00
- Email: contact@esclinicalresearch.com
-
Adrar, Algeria, Algeria, 01000
- Not yet recruiting
- CAC Adrar - Radiotherapy Department
-
Contact:
- FELLAG Houmem, Doctor
- Phone Number: +213 49 36 89 00
- Email: contact@esclinicalresearch.com
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Algiers, Algeria, Algeria, 16000
- Recruiting
- CAC BLIDA - Oncology Department
-
Contact:
- BOUNEDJAR Adda, Professor
- Phone Number: +213 25 20 90 72
- Email: contact@esclinicalresearch.com
-
Algiers, Algeria, Algeria, 16000
- Recruiting
- Centre Pierre et Marie Curie - Oncology Department
-
Contact:
- KEBOUA ESMA, Professor
- Phone Number: +213 23 55 96 80
- Email: contact@esclinicalresearch.com
-
Algiers, Algeria, Algeria, 16000
- Recruiting
- Centre Pierre et Marie Curie - Radiology Department
-
Contact:
- OUKRIF Séam, Professor
- Phone Number: +213 23 55 96 80
- Email: contact@esclinicalresearch.com
-
Algiers, Algeria, Algeria, 16000
- Recruiting
- CHU Bab El Oued
-
Contact:
- BELKACEM-NACER Abdelwahab, Professor
- Phone Number: +213 21 96 06 06
- Email: contact@esclinicalresearch.com
-
Algiers, Algeria, Algeria, 16000
- Recruiting
- CHU Béni Messous - Oncology Departement
-
Contact:
- Oukkal Mohammed, Professor
- Phone Number: +213 219 311 90
- Email: contact@esclinicalresearch.com
-
Algiers, Algeria, Algeria, 16000
- Recruiting
- EPH ROUIBA - Oncology Department
-
Contact:
- MAHFOUF Hassen, Professor
- Phone Number: +213 21 86 04 35
- Email: contact@esclinicalresearch.com
-
Annaba, Algeria, Algeria, 23000
- Recruiting
- CAC Annaba - Oncology Departement
-
Contact:
- DJEDDI Hanene, Professor
- Phone Number: +213 38 40 00 04
- Email: contact@esclinicalresearch.com
-
Annaba, Algeria, Algeria, 23000
- Recruiting
- CAC Annaba - Radiotherapy Department
-
Contact:
- NAOUN Lilia, Professor
- Phone Number: +213 38 40 00 04
- Email: contact@esclinicalresearch.com
-
Annaba, Algeria, Algeria, 23000
- Recruiting
- CAC Annaba - Urology Departement
-
Contact:
- CHETTIBI kheireddine, Professor
- Phone Number: +213 38 40 00 04
- Email: contact@esclinicalresearch.com
-
Blida, Algeria, Algeria, 09000
- Recruiting
- CAC Bida - Radiotherapy Department
-
Contact:
- HAOUI Messaouda, Professor
- Phone Number: +213 25 20 90 72
- Email: contact@esclinicalresearch.com
-
Blida, Algeria, Algeria, 09000
- Recruiting
- CAC BLIDA - Urology Department
-
Contact:
- OULD ARBI Sid Ahmed, Professor
- Phone Number: +213 25 20 90 72
- Email: contact@esclinicalresearch.com
-
Constantine, Algeria, Algeria, 25000
- Recruiting
- CHU Constantine - Oncology Departement
-
Contact:
- ZERROUK DALAL, Professor
- Phone Number: +213 31 88 66 22
- Email: contact@esclinicalresearch.com
-
Constantine, Algeria, Algeria, 25000
- Recruiting
- EH Constantine - Oncology Departement
-
Contact:
- BENSALEM Assia, Professor
- Phone Number: +213 31 88 66 22
- Email: contact@esclinicalresearch.com
-
Mostaganem, Algeria, Algeria, 27000
- Recruiting
- EPH Mostaghanem - Oncology Department
-
Contact:
- ZIDANE Habib, Professor
- Phone Number: +213 45 41 09 49
- Email: contact@esclinicalresearch.com
-
Oran, Algeria, Algeria, 31000
- Recruiting
- CAC ORAN - Oncology Department
-
Contact:
- LARBAOUI Blaha, Professor
- Phone Number: +213 20 33 91 20
- Email: contact@esclinicalresearch.com
-
Oran, Algeria, Algeria, 31000
- Recruiting
- CAC ORAN - Radiotherapy Department
-
Contact:
- BOUKERCHE Abdelbaki, Professor
- Phone Number: +213 20 33 91 20
- Email: contact@esclinicalresearch.com
-
Oran, Algeria, Algeria, 31000
- Not yet recruiting
- EHU ORAN - Oncology Department
-
Contact:
- BEREKSI REGUIG FAIZA, Professor
- Phone Number: +213 41 70 50 92
- Email: contact@esclinicalresearch.com
-
Oran, Algeria, Algeria, 31000
- Recruiting
- EHU ORAN - Urology Department
-
Contact:
- YOUSFI Mostafa Jamel, Professor
- Phone Number: +213 41 70 50 92
- Email: contact@esclinicalresearch.com
-
Sétif, Algeria, Algeria, 19000
- Recruiting
- CAC Sétif - Oncology Departement
-
Contact:
- DIB Adlane Husseine, Professor
- Phone Number: +213 36 45 45 45
- Email: contact@esclinicalresearch.com
-
Sétif, Algeria, Algeria, 19000
- Recruiting
- CAC Sétif - Radiotherapy Department
-
Contact:
- BOUDAOUD Khadidja, Professor
- Phone Number: +213 36 45 45 45
- Email: contact@esclinicalresearch.com
-
Tipasa, Algeria, Algeria, 42000
- Recruiting
- EPH Sidi Ghilès - Oncology Department
-
Contact:
- SEGHIER Fatma, Professor
- Phone Number: +213 24 33 12 25
- Email: contact@esclinicalresearch.com
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Tizi Ouzou, Algeria, Algeria, 15000
- Recruiting
- CAC Draa Ben Khedda - Radiotherapy Departement
-
Contact:
- BENZIDANE Kahina, Professor
- Phone Number: +213 549 30 70 71
- Email: contact@esclinicalresearch.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Socio-demographic characteristics of patients with prostate cancer in Algeria
Time Frame: At Baseline ( Initial visit )
|
Frequency (%) of sociodemographic characteristics of patients with prostate cancer in Algeria, including age at diagnosis, marital status, and socioeconomic level.
|
At Baseline ( Initial visit )
|
|
Personal and family history of cancer
Time Frame: At Baseline (Initial Visit)
|
Frequency (%) of patients with personal and family history of cancer.
|
At Baseline (Initial Visit)
|
|
Environmental and occupational exposures
Time Frame: At Baseline (Initial visit)
|
Frequency (%) of patients with environmental or occupational exposures.
|
At Baseline (Initial visit)
|
|
Smoking history
Time Frame: At Baseline (Initial visit)
|
Frequency (%) of patients according to smoking status (current, former, never).
|
At Baseline (Initial visit)
|
|
Alcohol consumption
Time Frame: At Baseline (Initial visit)
|
Frequency (%) of patients according to alcohol consumption (yes/no).
|
At Baseline (Initial visit)
|
|
Initial symptoms and circumstances of diagnosis
Time Frame: At Baseline (Initial visit)
|
Frequency (%) of patients according to type of initial symptoms and circumstances of diagnosis.
|
At Baseline (Initial visit)
|
|
Evolutionary status of patients
Time Frame: At Baseline (Initial visit)
|
Frequency (%) of patients according to disease status (in remission or with disease progression).
|
At Baseline (Initial visit)
|
|
International Prostate Symptom Score (IPSS)
Time Frame: 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.
|
At Baseline (Initial visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnosis by PSA testing
Time Frame: At Baseline (Initial visit)
|
% of patients diagnosed by PSA testing.
|
At Baseline (Initial visit)
|
|
Diagnosis by imaging
Time Frame: At Baseline (Initial visit)
|
% of patients diagnosed by imaging.
|
At Baseline (Initial visit)
|
|
Diagnosis by biopsy
Time Frame: At Baseline (Initial visit)
|
% of patients diagnosed by biopsy.
|
At Baseline (Initial visit)
|
|
Time from symptom onset to first medical consultation
Time Frame: At Baseline (Initial visit)
|
Median time (in days) between onset of first symptoms and first medical consultation.
|
At Baseline (Initial visit)
|
|
Time from first consultation to confirmed diagnosis
Time Frame: At Baseline (Initial visit)
|
Median time (in days) between first medical consultation and confirmed diagnosis.
|
At Baseline (Initial visit)
|
|
Patients discussed in multidisciplinary team meetings
Time Frame: At Baseline (Initial visit)
|
% of patients discussed in tumor boards / multidisciplinary team meetings.
|
At Baseline (Initial visit)
|
|
Initial treatment: Surgery
Time Frame: At Baseline (Initial visit)
|
% of patients receiving surgery as initial treatment.
|
At Baseline (Initial visit)
|
|
Initial treatment: Radiotherapy
Time Frame: At Baseline (Initial visit)
|
% of patients receiving radiotherapy as initial treatment.
|
At Baseline (Initial visit)
|
|
Initial treatment: Hormone therapy
Time Frame: At Baseline (Initial visit)
|
% of patients receiving hormone therapy as initial treatment.
|
At Baseline (Initial visit)
|
|
Initial treatment: Active surveillance
Time Frame: At Baseline (Initial visit)
|
% of patients under active surveillance as initial management.
|
At Baseline (Initial visit)
|
|
Time from diagnosis to treatment initiation
Time Frame: At Baseline (Initial visit)
|
Median time (in days) between diagnosis and treatment initiation.
|
At Baseline (Initial visit)
|
|
Specialty of physician initiating treatment
Time Frame: At Baseline (Initial visit)
|
Medical specialty of the physician initiating treatment (urologist, oncologist, etc.).
|
At Baseline (Initial visit)
|
|
Adverse events
Time Frame: At Baseline (Initial visit)
|
Frequency of adverse events by system/organ class and distribution according to severity grades (CTCAE grades 1 to 5).
|
At Baseline (Initial visit)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Pathologic Processes
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Pathological Conditions, Signs and Symptoms
- Neoplasms
- Prostatic Neoplasms
- Disease
- Adenocarcinoma
Other Study ID Numbers
- SAFRO 02.002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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