CancerNCT03951428
Screening of Cancer Through Novel Female Specific Biomarkers
An observational study of Cancer, run by LifeStory Health Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Menstrual Blood Screening Test
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Three sites will serve as participant recruitment: Baylor Scott \& White Medical Center - Hillcrest Baylor Scott \& White Medical Center - Round Rock Scott \& White Medical Center - Temple
Who may be able to join
- are 18 years or older
- are either healthy or have a recent diagnosis of breast, endometrial or lung cancer and have not yet begun treatment (your doctor will provide the stage of cancer at time of enrollment)
- are willing and able to comply with the study requirements
- have a negative pregnancy test prior to enrolling in this study
- Have provided all current medication usage and accurately reported disease history (both current and past) and completed the health profile provided at time of enrollment
- currently menstruating
Who cannot join
- have a generalized infection (bacterial, viral or fungal), or obvious localized infections in the vaginal area
- have any active sexually transmitted diseases•if you become pregnant while on the study, you must withdraw from the study.
- have received an investigational drug within four weeks prior to the study or who plan to use other investigational drugs duringthis study.
- have severe medical condition(s) that in the view of the investigator prohibits participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vasicek Cancer Treatment Center
Temple, Texas, 76508
Dedra Preece, BS, CCRP, 254-724-5939, Dedra.Preece@BSWHealth.org
About this study
Official title: Screening and Early Detection of Cancer Through Identification of Novel Female Specific Biomarkers Through Self-Collected Menstrual Blood
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.
Read the 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 women's 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 Health's (LSH's) Protocol and Instructions for Use. Samples will be collected in the participant's home according to LSH's Collection Protocol using EBF-Inc.'s 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 device.Samples will be processed according to LSH's 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 facilities/physicians. 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 collection,management 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 Inc.This randomized, double blind, controlled trial will enroll 60 patients.
- Conditions
- Cancer
- Being tested
- Menstrual Blood Screening Test
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual Blood Screening TestDiagnostic test
The sponsor will be testing women's menstrual blood to investigate the feasibility and efficacy of assessing three early stage cancers via self-collected menstrual blood using FDA approved devices.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Not described Receives: Diagnostic Test: Menstrual Blood Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use UPLC UHR-MS and UPLC IM-MS to confirm previous findings of unique signatures in menstrual blood. The sponsor will additionally measure and new biomarkers in menstrual blood for early detection of breast, endometrial, and lung cancers.
UHR-MS and IM-MS, in parallel, for proteomics analysis of MB. These two approaches offer complementary advantages for comprehensive proteomic studies and assure detection of low abundance and post-translationally modified proteins in complex mixtures.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start15 May 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeStory Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baylor Scott and White Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951428
- Sponsor's protocol ID
- LSHBSWMBC
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Early Detection of Cancer Through Identification of Novel Female Specific Biomarkers Through Self-Collected Menstrual Blood
- ClinicalTrials.gov ID
- NCT03951428
- Acronym / sponsor ID
- LSHBSWMBC
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- LifeStory Health Inc.Industry (pharma, biotech, devices)
- Collaborators
- Baylor Scott and White Health
- Study start
- 15 May 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 15 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 women's 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 Health's (LSH's) Protocol and Instructions for Use. Samples will be collected in the participant's home according to LSH's Collection Protocol using EBF-Inc.'s 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 device.Samples will be processed according to LSH's 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 facilities/physicians. 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 collection,management 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 Inc.This randomized, double blind, controlled trial will enroll 60 patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Diagnostic Test: Menstrual Blood Screening Test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Three sites will serve as participant recruitment: Baylor Scott \& White Medical Center - Hillcrest Baylor Scott \& White Medical Center - Round Rock Scott \& White Medical Center - Temple
Key inclusion criteria (6 listed)
- are 18 years or older
- currently menstruating
Key exclusion criteria (4 listed)
- have a generalized infection (bacterial, viral or fungal), or obvious localized infections in the vaginal area
- have any active sexually transmitted diseases•if you become pregnant while on the study, you must withdraw from the study.
- have received an investigational drug within four weeks prior to the study or who plan to use other investigational drugs duringthis study.
- have severe medical condition(s) that in the view of the investigator prohibits participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menstrual Blood Screening TestThe sponsor will be testing women's menstrual blood to investigate the feasibility and efficacy of assessing three early stage cancers via self-collected menstrual blood using FDA approved devices. | Diagnostic test | All Participants |
Primary outcome
Use UPLC UHR-MS and UPLC IM-MS to confirm previous findings of unique signatures in menstrual blood. The sponsor will additionally measure and new biomarkers in menstrual blood for early detection of breast, endometrial, and lung cancers.
Time frame: 8 weeks
UHR-MS and IM-MS, in parallel, for proteomics analysis of MB. These two approaches offer complementary advantages for comprehensive proteomic studies and assure detection of low abundance and post-translationally modified proteins in complex mixtures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by LifeStory Health Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Villarreal, JD (512-660-8201, anna@annavillahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use UPLC UHR-MS and UPLC IM-MS to confirm previous findings of unique signatures in menstrual blood. The sponsor will additionally measure and new biomarkers in menstrual blood for early detection of breast, endometrial, and lung cancers. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.