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

NCT04671498 | Unknown

• 3 other identifiers: 2020-0724NCI-2020-08583MOD00009113 / IC-1243721
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 3

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

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Sensitivity of the Droplet-BC screening test for detecting breast cancer

  Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  Up to study completion (estimated 18 months)

• Specificity of the Droplet-BC screening test for detecting breast cancer

  Assessed within subgroups of participants determined by cancer history, medication, family history of cancer, and/or BRCA status.

  Up to study completion (estimated 18 months)

Secondary Outcomes (13)

• Sensitivity of the Droplet-BC screening test for the classification of early-stage breast cancer (BC)

  Up to study completion (estimated 18 months)

• Specificity of the Droplet-BC screening test for the classification of early-stage breast cancer

  Up to study completion (estimated 18 months)

• 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

  Up to study completion (estimated 18 months)

• 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

  Up to study completion (estimated 18 months)

• 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)

  Up to study completion (estimated 18 months)

Study Arms (2)

Ancillary-correlative (biospecimen collection) (Breast Cancer patients)

Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.

Procedure: Biospecimen Collection; Procedure: Droplet-BC Test; Other: Electronic Health Record Review

Ancillary-correlative (biospecimen collection) (Volunteer)

Participants undergo collection of blood sample for the Droplet-BC test. All participants' medical records are also reviewed.

Procedure: Biospecimen Collection; Procedure: Droplet-BC Test; Other: Electronic Health Record Review

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood sample

Ancillary-correlative (biospecimen collection) (Breast Cancer patients); Ancillary-correlative (biospecimen collection) (Volunteer)

Droplet-BC Test PROCEDURE

Undergo Droplet-BC Test

Ancillary-correlative (biospecimen collection) (Breast Cancer patients); Ancillary-correlative (biospecimen collection) (Volunteer)

Electronic Health Record Review OTHER

Medical records are reviewed

Ancillary-correlative (biospecimen collection) (Breast Cancer patients); Ancillary-correlative (biospecimen collection) (Volunteer)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients and non-cancer volunteers.

You may qualify if:

• 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 or other participating sites
• NON-CANCER VOLUNTEERS: Age \>= 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Preferred Medicine, Inc: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (3)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Naoto T Ueno

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naoto T Ueno

CONTACT

713-792-2817; nueno@mdanderson.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 17, 2020
• Study Start: November 3, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Locations

US (3)