Breast CancerNCT03243877
Performance of MammoAlert™, Point of Care System, for the Screening of Breast Cancer in Women 18 Years of Age or Older
An observational study of Breast Cancer, run by POC Medical Systems, Inc. at 7 sites in India.
Trial summary
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MammoAlert Screening Test
- How many people
- 2,458 participants
- Where
- 7 sitesIndia
- Study dates
- 17 Jun 2017to 31 Aug 2018
- 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
- Adult, Older adult
Study population: The present study targets women of at least 18 years old
Who may be able to join
- Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample
- Documented absence of cancer (other than Breast Cancer)
- Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage
- Blood sample taken before any treatment for Breast Cancer was administered to the subject.
Who cannot join
- Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.
- Therapies for breast cancer that have been administered within 1 year of obtaining the sample
- Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating in the study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
India7 sites
HCG MULTI Specialty Hospital HCG Cancer Center
Ahmedabad, Gujarat, 380006
Manipal Hospital
Bangalore, Karnataka, 560017
KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals
Hyderabad, Andhra Pradesh, 500003
Indo American Cancer Hospital and Research Institute
Hyderabad, Andhra Pradesh, 500034
Amrita Institute of Medical Sciences and Research Centre
Kochi, Kerala
Tata Medical Center
Kolkata, West Bengal, 700160
Maulana Azad Medical College University of Delhi & Associated Lok Nayak Hospital
New Delhi, 110002
About this study
Official title: Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. The present study aims to determine the Sensitivity and Specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.
Read the detailed description
2400 subjects will be screened for breast cancer in seven enrolling sites across the country to ensure diverse ethnicity.
"Positive" subjects should be confirmed breast cancer positive by Mammography and/or biopsy. Breast cancer positive samples will be compared to the control group of samples obtained from women attending clinics for non-cancerous related pathology.
Both Positive and Negative Predictive Values will be evaluated to determine accuracy and sensitivity of the screening test.
Subjects whose known cancer positive or negative status do not match the test report will be followed up as appropriate, on case by case basis to identify false positive and false negative results.
- Conditions
- Breast Cancer
- Being tested
- MammoAlert Screening Test
- Keywords
- Screening, Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammoAlert Screening TestOther
Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Positive | A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were positive.
MammoAlert Screening Test will be performed on plasma obtained from the blood sample. Receives: Other: MammoAlert Screening Test | |
| Breast Cancer Negative | A 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were negative.
MammoAlert Screening Test will be performed on plasma obtained from the blood sample. Receives: Other: MammoAlert Screening Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening performance (i.e., sensitivity and specificity)
Screening performance: comprises the sensitivity and specificity of MammoAlert™. It represents the performance of the diagnostic test and is therefore independent of the prevalence of the disease in the studied sample of patients.
Measured: Screening performance will be calculated at 4-months
Secondary outcomes (1)
Predictive values & likelihood ratios
Positive predictive value: the probability that a subject has the disease given that the test result is positive will be estimated by: TP/(TP+FP).
Negative predictive value: the probability that a subject does not have the disease given that the result of the test is negative will be estimated by TN/(TN+FN).
Likelihood ratio (LR): the likelihood that a given test result would be expected in a patient with the target disorder compared to the likelihood that that same result would be expected in a patient without the target disorder.
Measured: Predictive values & likelihood ratios will be calculated at 4-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start17 Jun 2017
- Primary completion26 Nov 2017
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,458 participants (actual)
Sponsor and investigators
- Lead sponsor
- POC Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raghu Ram Pillarisetti, MD, Principal investigator, KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03243877
- Sponsor's protocol ID
- POC-BC-0217
- Status last verified
- Apr 2018
- First submitted
- 25 Jul 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Centric Screening of Breast Cancer Patients to Determine Efficiency and to Assess Sensitivity & Accuracy of Pandora CDx MammoAlertTM in Screening of Breast Cancer.
- ClinicalTrials.gov ID
- NCT03243877
- Acronym / sponsor ID
- POC-BC-0217
- Conditions
- Breast Cancer
- Keywords
- Screening, Mammography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,458 participants (actual)
- Lead sponsor
- POC Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2017 (actual)
- Primary completion
- 26 Nov 2017 (actual)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 9 Aug 2017 (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.
POC Medical Systems has developed a Point of Care system for the screening of breast cancer in the general population. Via a proprietary algorithm, the MammoAlert™ is expected to determine breast cancer's risk level for a subject by identifying the presence in plasma of known biomarkers. The present study aims to determine the Sensitivity and Specificity of the test in plasma samples of subjects of whom the status vis-à-vis breast cancer is known.
Detailed description
2400 subjects will be screened for breast cancer in seven enrolling sites across the country to ensure diverse ethnicity.
"Positive" subjects should be confirmed breast cancer positive by Mammography and/or biopsy. Breast cancer positive samples will be compared to the control group of samples obtained from women attending clinics for non-cancerous related pathology.
Both Positive and Negative Predictive Values will be evaluated to determine accuracy and sensitivity of the screening test.
Subjects whose known cancer positive or negative status do not match the test report will be followed up as appropriate, on case by case basis to identify false positive and false negative results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Positive | – | Other: MammoAlert Screening TestA 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were positive. MammoAlert Screening Test will be performed on plasma obtained from the blood sample. |
| Breast Cancer Negative | – | Other: MammoAlert Screening TestA 5cc blood sample will be collected from subjects who were screened for breast cancer at the treating facility and results were negative. MammoAlert Screening Test will be performed on plasma obtained from the blood sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- The present study targets women of at least 18 years old
Key inclusion criteria (4 listed)
- Ability to give informed consent. Written informed consent by the patient/patient's legally acceptable representative (LAR) for donating blood sample
- Documented absence of cancer (other than Breast Cancer)
- Documented (Mammography and/or Biopsy) diagnosis of Breast Cancer (IDC/ILC/DCIS ), any stage
- Blood sample taken before any treatment for Breast Cancer was administered to the subject.
Key exclusion criteria (3 listed)
- Other malignancy besides breast cancer in the 5 years prior to obtaining the sample.
- Therapies for breast cancer that have been administered within 1 year of obtaining the sample
- Any condition (including psychiatric), which in the Investigator's opinion, places the patient at undue risk by participating 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 |
|---|---|---|
| MammoAlert Screening TestPlasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers. | Other | Breast Cancer Negative, Breast Cancer Positive |
Primary outcome
Screening performance (i.e., sensitivity and specificity)
Time frame: Screening performance will be calculated at 4-months
Screening performance: comprises the sensitivity and specificity of MammoAlert™. It represents the performance of the diagnostic test and is therefore independent of the prevalence of the disease in the studied sample of patients.
1 secondary outcome
Predictive values & likelihood ratios
Time frame: Predictive values & likelihood ratios will be calculated at 4-months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Raghu Ram Pillarisetti, MD principal investigator
KIMS USHALAKSHMI Centre for Breast Diseases KIMS Hospitals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by POC Medical Systems, Inc. at 7 sites in India.
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 4 inclusion and 3 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 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening performance (i.e., sensitivity and specificity) (time frame: Screening performance will be calculated at 4-months). 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 11 Apr 2018.