Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059407) titled 'A case-control clinical evaluation of the Exact Sciences Multi-Cancer Early Detection(MCED) in Japan' on Oct. 15.

Study Type: Observational

Primary Sponsor: Institute - National Cancer Center Hospital East

Condition: Condition - Solid tumors or malignant lymphomas confirmed histologically, excluding non-melanoma skin cancer, with a focus on 16 types of cancer with particularly high incidence rates in Japan (lung, stomach, prostate, colorectum, breast, liver, pancreas, bladder/renal pelvis, non-hodgkin lymphoma, esophagus, kidney, uterine body, uterine cervix, ovary, bile duct, and head and neck). Classification by malignancy - Malignancy Genomic information - YES

Objective: Narrative objectives1 - To evaluate the overall sensitivity and specificity of Exact Sciences' MCED test in the Japanese population. Basic objectives2 - Others

Eligibility: Age-lower limit - 45 years-old = Gender - Male and Female Key inclusion criteria - All cohorts 1. Age 45 up to and including 84 years at time of consent . 2. Understand the content of the study and have given written consent to participate in this study. 3. Japanese descent or Japanese nationals residing in Japan. 4. Be able to provide approximately 51 ml of peripheral blood .

Non-cancer cohort only 5. Self-reported having undergone screening for gastric, colorectal, lung, breast, and cervical cancer as recommended by the Japanese Cancer Screening Program. Considering the variations in gender, age, smoking index, and timing of screening examinations, the criteria for each cancer type are defined as follows. a. Gastric cancer: For men and women aged 50 years and older, a gastric x-ray or gastric endoscopy within the past 30 months. b. Colorectal cancer: For men and women aged 40 years and older who have had a fecal occult blood test (immunoassay) within the past 15 months. c. Lung cancer: For men and women 40 years of age or older, a chest X-ray within the past 15 months. d. Lung cancer: Sputum cytology within the past 15 months for men and women aged 50 years and older with a smoking index of 600 or higher. (Smoking index = number of cigarettes per day x years of smoking) e.Breast cancer: For women 40 years of age and older, mammography within the past 30 months. f. Cervical cancer: For women 40 years of age or older, cervical cytology within the past 30 months. 6. Not planning to leave Japan for permanent residence in another country within 12 months of blood sample collection. 7. Willing to confirm continued cancer-free status approximately 12 months after blood sample collection.

Cancer cohort only 8. Suspected cancer or diagnosed cancer. Key exclusion criteria - All cohorts 1. Received chemotherapy and/or radiation therapy for any medical condition within 5 years prior to enrollment. 2. Underwent core needle biopsy or puncture aspiration cytology for any reason within 3 days prior to blood sample collection. 3. Underwent an incisional or excisional biopsy for any reason within 7 days prior to blood sample collection. 4. The principal investigator determines that the participant is inappropriate for this study. 5. Have an infectious disease with fever at the time of blood collection. 6. Have a history of allogeneic bone marrow transplantation, stem cell transplantation, or solid organ transplantation, or is scheduled to undergo such transplantation prior to blood sample collection. 7. Current primary diagnosis of stage 0, intraepithelial carcinoma (including DCIS and LCIS).

Cancer cohort only 8.Have a history of cancer, including solid tumors or hematologic malignancies. However, if the cancer was treated and has not recurred for more than 5 years after treatment, it is not included in the history of cancer as an exclusion criterion. 9. Concurrent diagnosis of multiple (newly diagnosed) primary cancers. 10. Have hematologic malignancies other than malignant lymphoma. 11. Current primary diagnosis of non-invasive basal cell carcinoma or squamous cell carcinoma. 12. Local or systemic anti-cancer therapy for the newly diagnosed cancer (e.g., surgical resection, radiation therapy, and/or systemic anticancer therapy including chemotherapy, endocrine therapy, immunotherapy, molecular targeted therapy, or other biological control) has been initiated or will be initiated before the blood sample is collected.

Non-cancer cohort only 13. Have a history of cancer, including solid tumors or hematologic cancers. 14. Clinically suspected active malignancy. 15. Positive screening test result for cancer (confirmed or unconfirmed on close examination) within 3 years prior to enrollment. Target Size - 2000

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 18 Day Date of IRB - 2025 Year 09 Month 18 Day Anticipated trial start date - 2025 Year 10 Month 27 Day Last follow-up date - 2028 Year 02 Month 29 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066911

Disclaimer: Curated by HT Syndication.