Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03951428
Status:
UNKNOWN
Last Update Posted:
2019-05-15
First Post:
2019-05-13
Brief Title:
Screening of Cancer Through Novel Female Specific Biomarkers
Sponsor:
LifeStory Health Inc
Organization:
LifeStory Health Inc
Study Overview
Official Title:
Screening and Early Detection of Cancer Through Identification of Novel Female Specific Biomarkers Through Self-Collected Menstrual Blood
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Can reliable biomarkers be identified for detection of cancer at early stages using menstrual blood MB Preliminary mass spectrometry MS results suggest that MB provides biomarkers for identification of disease such as cancers
Detailed Description:
The sponsor will first analyze menstrual blood MB samples in three discreet studies breast endometrial lung According to American Institute for Cancer Research Endometrial cancer is the most common cancer of the female reproductive organs More cases of endometrial cancer occur each year than ovarian and cervical cancers combined 20 to 25 will be diagnosed with endometrial cancer before menopause Based on the patient recruitment potential and high impact on womens health these three cancer types are suitable models to evaluate the expediency of utilizing MB as an ideal source for identification of cancer markers
Health profiles are completed by all participants and where applicable and possible patient medical records health tracking device data etc will be included Blood samples will be collected as indicated on the collection protocol outlined by LifeStory Healths LSHs Protocol and Instructions for Use Samples will be collected in the participants home according to LSHs Collection Protocol using EBF-Incs 903 dried blood spot DBS collection device prior shipment to the research center Samples should be sent within 3 days of collection Up to one-hundred and fifty micro-liters 150 uL of menstrual blood can be collected from donors using the collection deviceSamples will be processed according to LSHs protocol and any methods outlined in this development plan
The study will receive samples from 60 female participants totaling 30 samples from early-stage cancer patients and 30 samples from healthy women After initial determination of potential cancer markers for all three cancer types the sponsor will select a single cancer type with the most promising results Cancer 1 and carry out additional statistically higher-powered studies on all four stages of this selected cancer After the identities of potential MB biomarkers for a single cancer type are re-confirmed and established at the highest level of confidence simple assays will be developed for cost-effective detection of target proteoforms for early detection of cancer
Overall conduct of the study is the responsibility of the recruiting facilitiesphysicians LifeStory Health provides operational oversight The Baylor Scott and White Research Division BSW is responsible for oversight of the Regional Centers LifeStory Health is responsible for data collectionmanagement and analysis Study patient safety and study performance are monitored by BSW This study is being conducted with LifeStory Health and principal investigator Anna Villarreal CEO and Founder of LifeStory Health IncThis randomized double blind controlled trial will enroll 60 patients
Health profiles are completed by all participants and where applicable and possible patient medical records health tracking device data etc will be included Blood samples will be collected as indicated on the collection protocol outlined by LifeStory Healths LSHs Protocol and Instructions for Use Samples will be collected in the participants home according to LSHs Collection Protocol using EBF-Incs 903 dried blood spot DBS collection device prior shipment to the research center Samples should be sent within 3 days of collection Up to one-hundred and fifty micro-liters 150 uL of menstrual blood can be collected from donors using the collection deviceSamples will be processed according to LSHs protocol and any methods outlined in this development plan
The study will receive samples from 60 female participants totaling 30 samples from early-stage cancer patients and 30 samples from healthy women After initial determination of potential cancer markers for all three cancer types the sponsor will select a single cancer type with the most promising results Cancer 1 and carry out additional statistically higher-powered studies on all four stages of this selected cancer After the identities of potential MB biomarkers for a single cancer type are re-confirmed and established at the highest level of confidence simple assays will be developed for cost-effective detection of target proteoforms for early detection of cancer
Overall conduct of the study is the responsibility of the recruiting facilitiesphysicians LifeStory Health provides operational oversight The Baylor Scott and White Research Division BSW is responsible for oversight of the Regional Centers LifeStory Health is responsible for data collectionmanagement and analysis Study patient safety and study performance are monitored by BSW This study is being conducted with LifeStory Health and principal investigator Anna Villarreal CEO and Founder of LifeStory Health IncThis randomized double blind controlled trial will enroll 60 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None