UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059407 |
|---|---|
| Receipt number | R000066911 |
| Scientific Title | A case-control clinical evaluation of the Exact Sciences Multi-Cancer Early Detection(MCED) in Japan |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/15 09:10:09 |
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Basic information
Public title
A case-control clinical evaluation of the Exact Sciences Multi-Cancer Early Detection(MCED) in Japan
Acronym
CRANE
Scientific Title
A case-control clinical evaluation of the Exact Sciences Multi-Cancer Early Detection(MCED) in Japan
Scientific Title:Acronym
CRANE
Region
| Japan |
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 specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Nephrology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Oto-rhino-laryngology |
| Urology | Oral surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the overall sensitivity and specificity of Exact Sciences' MCED test in the Japanese population.
Basic objectives2
Others
Basic objectives -Others
To evaluate the sensitivity of Exact Sciences' MCED test in subgroups (including, but not limited to, by cancer type, clinical stage, and combination of cancer type and stage).
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the overall sensitivity(across all cancer types and stages) and specificity for the Exact Sciences' MCED test .
Key secondary outcomes
To evaluate the sensitivity for the Exact Sciences' MCED test for subgroups including, but not limited to: individual, cancer type, clinical stage, and individual cancer type and stage.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 45 | years-old | <= |
Age-upper limit
| 84 | 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 sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Takeaki |
| Middle name | |
| Last name | Yamazaki |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Endoscopy
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
tayamaz2@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Exact Sciences
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Exact Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道大学病院（北海道）、埼玉医科大学国際医療センター（埼玉県）、国立がん研究センター東病院（千葉県）、がん研有明病院（東京都）、杏林大学医学部付属病院（東京都）、慶應義塾大学病院（東京都）、聖マリアンナ医科大学病院（神奈川県）、神奈川県立がんセンター（神奈川県）、静岡がんセンター（静岡県）、愛知県がんセンター（愛知県）、岐阜大学医学部附属病院（岐阜県）、大阪大学医学部附属病院（大阪府）、近畿大学病院（大阪府）、関西医科大学附属病院（大阪府）、関西ろうさい病院（兵庫県）、四国がんセンター（愛媛県）、九州大学病院（福岡県）、北海道対がん協会（北海道）、鹿児島県民総合保健センター（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to evaluate the overall sensitivity and specificity of Exact Sciences' MCED test in the Japanese population.
Management information
Registered date
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066911
