Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059322) titled 'Development of a real-world database for cancer patients in Japan' on Oct. 8.
Study Type:
Observational
Primary Sponsor:
Institute - Institute of Science Tokyo Hospital
Condition:
Condition - - Breast cancer
- Gastrointestinal cancers (esophageal cancer, gastroesophageal junction cancer, gastric cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer, gallbladder cancer, duodenal papillary carcinoma, intrahepatic bile duct cancer, gastrointestinal stromal cancer, small bowel cancer (including duodenal cancer), primary neuroendocrine tumor of the digestive tract, etc.)
- Lung cancer (non-small cell lung cancer, small cell lung cancer, etc.)
- Prostate cancer
- Renal cancer
- Urothelial carcinoma (bladder cancer, ureter cancer, and renal pelvis cancer, etc.)
- Hematopoietic malignancies (leukemia, malignant lymphoma, multiple myeloma, myeloproliferative disorders, etc.)
Classification by malignancy - Malignancy
Genomic information - YES
Objective:
Narrative objectives1 - To curate high-quality oncology real-world data based on existing and future medical records at the Institute of Science Tokyo Hospital, for the furtherance of research and medical care for cancer in Japan
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who meet all of the following criteria will be included in this study:
1. Patients who visited the Institute of Science Tokyo Hospital between January 1, 2011 and June 30, 2029.
2. Diagnosed with one of the following types of cancer.
- Breast cancer
- Gastrointestinal cancers (esophageal cancer, gastroesophageal junction cancer, gastric cancer, colorectal cancer, hepatocellular carcinoma, pancreatic cancer, gallbladder cancer, duodenal papillary carcinoma, intrahepatic bile duct cancer, gastrointestinal stromal cancer, small bowel cancer (including duodenal cancer), primary neuroendocrine tumor of the digestive tract, etc.)
- Lung cancer (non-small cell lung cancer, small cell lung cancer, etc.)
- Prostate cancer
- Renal cancer
- Urothelial carcinoma (bladder cancer, ureter cancer, and renal pelvis cancer, etc.)
- Hematopoietic malignancies (leukemia, malignant lymphoma, multiple myeloma, myeloproliferative disorders, etc.)
3. Patients aged 18 and above
4. Patient(or a legal surrogate) has either confirmed willingness to participate in the study through one of the following methods, or has not expressed a decline to participate.
- Written informed consent has been obtained using study-specific explanatory and consent documents.
- For eligible patients who visited the institution on or after January 1, 2011, and are already deceased, no objection to participation has been received from the patient's legal surrogate after being provided with an opportunity to decline participation in this study,provided that this does not contradict the explicit wishes expressed by the patient during their lifetime.
Surrogate: Spouse, parents, siblings, children/grandchildren, grandparents, relatives living together with the subject patient, or persons considered to be equivalent to such close relatives (excluding minors).
Key exclusion criteria - None
Target Size - 7800
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2024 Year 10 Month 22 Day
Date of IRB - 2024 Year 10 Month 22 Day
Anticipated trial start date - 2025 Year 01 Month 08 Day
Last follow-up date - 2029 Year 06 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067464
Disclaimer: Curated by HT Syndication.