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Droplet-BC Screening Test for the Detection of Breast Cancer, the DROPLET-BC Study

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ClinicalTrials.gov Identifier: NCT04671498
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
Preferred Medicine, Inc

Brief Summary:
This study investigates if a new type of test called Droplet-BC screening test can classify breast cancer patients from non-cancer volunteers by circulating small-noncoding RNA in the blood with a statistical validity. This study also investigates if this test can classify the subgroup of breast cancer patients with a variety of conditions. Information from this study may provide a new method of breast cancer screening/diagnosis

Condition or disease Intervention/treatment
Breast Carcinoma Procedure: Biospecimen Collection Procedure: Droplet-BC Test Other: Electronic Health Record Review

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Detection by Circulating RNA With Optimized Machine Learning Technology for Breast Cancer: DROPLET-BC Study
Actual Study Start Date : November 3, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Ancillary-correlative (biospecimen collection)
Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.
Procedure: Biospecimen Collection
Undergo collection of blood sample

Procedure: Droplet-BC Test
Undergo Droplet-BC Test

Other: Electronic Health Record Review
Medical records are reviewed




Primary Outcome Measures :
  1. Sensitivity of the Droplet-BC screening test for detecting breast cancer [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  2. Specificity of the Droplet-BC screening test for detecting breast cancer [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.


Secondary Outcome Measures :
  1. Sensitivity of the Droplet-BC screening test for the classification of early-stage breast cancer (BC) [ Time Frame: Up to study completion (estimated 18 months) ]
    Early-stage means breast ductal carcinoma in situ (DCIS) stage and stage I/II BC. Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  2. Specificity of the Droplet-BC screening test for the classification of early-stage breast cancer [ Time Frame: Up to study completion (estimated 18 months) ]
    Early-stage means DCIS stage and stage I/II BC. Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  3. Sensitivity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (Breast Imaging Reporting and Data System [BI-RADS] categories 1 and 2) and BC patient subgroups [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  4. Specificity of the Droplet-BC screening test for the classification of patients into non-cancer volunteer (BI-RADS categories 1 and 2) and BC patient subgroups [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  5. Sensitivity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2) [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  6. Specificity of the Droplet-BC screening test for the classification of different subgroups between non-cancer volunteers (BIRADS category 1) and BC patients plus non-cancer volunteers (BI-RADS category 2) [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  7. Sensitivity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study) [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  8. Specificity of the Droplet-BC screening test for the classification of non-cancer volunteers into BI-RADS categories 0-5 (small cohort study) [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  9. Sensitivity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  10. Specificity of the Droplet-BC screening test for the classification of BC patients into cancer stages 0-IV [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  11. Sensitivity of the Droplet-BC test compared with mammogram for detecting BC by extracting a subgroup of BC patients that have mammogram results [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  12. Sensitivity of the Droplet-BC test compared with ultrasound for detecting BC by extracting a subgroup of BC patients that have ultrasound results [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  13. Sensitivity of Droplet-BC test compared with magnetic resonance imaging (MRI) for detecting BC by extracting a subgroup of BC patients that have MRI results [ Time Frame: Up to study completion (estimated 18 months) ]
    Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Breast cancer patients and non-cancer participants at MD Anderson Cancer Center.
Criteria

Inclusion Criteria:

  • BREAST CANCER PATIENTS: Newly diagnosed with breast cancer
  • BREAST CANCER PATIENTS: Not received cancer treatment for newly diagnosed with breast cancer
  • BREAST CANCER PATIENTS: Able to comprehend, sign, and date the written informed consent document to participate in the study
  • BREAST CANCER PATIENTS: Able and willing to provide a one-time blood sample
  • BREAST CANCER PATIENTS: Age >= 18 years old
  • NON-CANCER VOLUNTEERS: Have undergone a screening mammogram
  • NON-CANCER VOLUNTEERS: Not currently taking any drugs for cancer treatment or any cancer prevention medication
  • NON-CANCER VOLUNTEERS: Able to comprehend, sign, and date the written informed consent document to participate in this study
  • NON-CANCER VOLUNTEERS: Able and willing to provide blood samples according to provided written instructions
  • NON-CANCER VOLUNTEERS: Seen by a provider (physician or advanced practice nurse [APN]) in the Cancer Prevention clinic at MD Anderson Cancer Center
  • NON-CANCER VOLUNTEERS: Age >= 18 years old

Exclusion Criteria:

  • BREAST CANCER PATIENTS: Known current pregnancy
  • BREAST CANCER PATIENTS: History of breast cancer treatment in the past
  • BREAST CANCER PATIENTS: Participation in any interventional clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
  • BREAST CANCER PATIENTS: Any condition that, in the opinion of the investigator, should preclude participation in the study
  • NON-CANCER VOLUNTEERS: Known current pregnancy
  • NON-CANCER VOLUNTEERS: History of breast cancer (breast ductal carcinoma in situ [DCIS] and invasive)
  • NON-CANCER VOLUNTEERS: History of any cancer except non-melanoma skin cancer and cervical dysplasia
  • NON-CANCER VOLUNTEERS: Participation in any interventional clinical study within the previous 30 days in which experimental treatment is administered or might be administered through a randomized assignment of the subject to one or more study groups
  • NON-CANCER VOLUNTEERS: Any condition that in the opinion of the investigator, should preclude participation in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671498


Contacts
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Contact: Naoto T Ueno 713-792-2817 nueno@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Naoto T. Ueno    713-792-2817      
Principal Investigator: Naoto T. Ueno         
Sponsors and Collaborators
Preferred Medicine, Inc
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Naoto T Ueno M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: Preferred Medicine, Inc
ClinicalTrials.gov Identifier: NCT04671498    
Other Study ID Numbers: 2020-0724
NCI-2020-08583 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2020-0724 ( Other Identifier: M D Anderson Cancer Center )
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases