Breast Neoplasms Clinical Trial
— To-Be 2Official title:
Digital Breast Tomosynthesis - The Future Screening Tool for Breast Cancer?
Verified date | September 2023 |
Source | Cancer Registry of Norway |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to compare early performance measures and economic aspects of organized breast cancer screening for women screened using digital breast tomosynthesis+synthetic mammography (DBT+SM) to women with a prior DBT+SM or digital mammography (DM) from To-Be 1 (NCT02835625).
Status | Completed |
Enrollment | 31082 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 48 Years to 71 Years |
Eligibility | Inclusion Criteria: - Written, informed consent to participation Exclusion Criteria: - No written, informed consent to participation - Breast implants |
Country | Name | City | State |
---|---|---|---|
Norway | Cancer Registry of Norway | Oslo |
Lead Sponsor | Collaborator |
---|---|
Cancer Registry of Norway | Haukeland University Hospital, Norwegian Cancer Society, University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare rates of screen detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. | Rate of screening detected breast cancer, among those screened | 48 months from start up of the trial | |
Secondary | Compare recall rates after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. | Rate of recalled women due to mammographic findings, among those screened | 48 months from start up of the trial | |
Secondary | Positive predictive value of recalls after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. | Rate of breast cancer cases among those recalled | 48 months from start up of the trial | |
Secondary | Prognostic and predictive tumor characteristics for screening detected breast cancer after subsequent screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. | Distribution of characteristics among the women diagnosed with breast cancer | 48 months from start up of the trial | |
Secondary | Rate of interval breast cancer following screening with DBT+SM after DBT+SM versus screening with DBT+SM after prior DM, as performed in a population based screening program. | Rates and prognostic and predictive tumor characteristics of interval cancer among women screened in To-Be 1, stratified by mammographic density. | 48 months from start up of the trial | |
Secondary | Rate of missed and true screen-detected and interval breast cancer in mammographic screening with DBT+SM versus DM. | Retrospective review of prior and actual mammograms from women with interval and screen-detected breast cancers detected in To-Be 1 and 2, respectively. | 24-48 month after start up of the trial | |
Secondary | Economical aspects of continuous use of DBT+SM | Estimation of the financial impact of running a screening program with DBT+SM in an everyday setting. | 48 months from start up of the trial | |
Secondary | Comparing interpretation times to investigate possible learning effects when reading DBT+SM in two consecutive screening rounds | Evaluation of difference in interpretation time for subsequent versus prevalent DBT+SM screens | 48 months from start up of the trial | |
Secondary | Assessing degree of experienced and expected pain in DBT+SM screening by compression pressure using questionnaire | Explore whether individualized, standardized compression pressure influences women's screening experiences using a numeric rating scale (0 "No discomfort/pain" to 10 "Very much discomfort/pain"). Drafting of the questionnaire is in progress. | 6 to 48 months after start up of the trial |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT03664778 -
Abbreviated Breast MRI After Cancer Treatment
|
||
Recruiting |
NCT03144622 -
18F-FSPG PET/CT Imaging in Patients With Cancers
|
||
Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
Active, not recruiting |
NCT04568902 -
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT02860585 -
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03698942 -
Delphinus SoftVueâ„¢ ROC Reader Study
|
||
Completed |
NCT00092950 -
Exercise in Women at Risk for Breast Cancer
|
Phase 2 | |
Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02151071 -
The Breast Surgery EnLight and LightPath Imaging System Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT02934360 -
TR(ACE) Assay Clinical Specimen Study
|
N/A | |
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A | |
Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
N/A |