Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058510) titled 'A Study on Cancer Screening for Individuals with Inconclusive NIPT Results' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Hokkaido University Hospital
Condition:
Condition - Individuals with inconclusive NIPT results
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This study aimed to elucidate the association between inconclusive results of non-invasive prenatal testing (NIPT) and maternal malignancies by performing whole-body MRI-based cancer screening in pregnant women with inconclusive NIPT findings.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - MRI scan
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Female
Key inclusion criteria - 1.Individuals aged 18 years or older at the time of obtaining consent.
2.Pregnant individuals at 14 weeks of gestation or later, with an ongoing pregnancy and eligible for whole-body MRI.
3.Individuals who have received a thorough explanation of the study, fully understood its contents, and voluntarily provided written informed consent to participate.
Key exclusion criteria - 1.Individuals with contraindications to MRI examinations (e.g., metallic implants, pacemakers).
2.Individuals with a history of malignant tumors.
3.Individuals deemed inappropriate for participation in the study by the principal investigator for any other reason.
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 14 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2031 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066854
Disclaimer: Curated by HT Syndication.
