NCT04488614

Brief Summary

Prospective Breast Cancer Biobanking study (PBCB) will apply advanced monitoring in liquid biopsies of early staged breast cancer ration in order to facilitate A. Early detection of systemic relapses B.Improve adherence and drug monitoring av tamoxifen treatment C. Tumour microenvironment in breast cancer - adipose stromal immune infiltration and interaction with tumour at the growth zone D.Monitor side effects, QoL, depression, fatigue and work life participation

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
51mo left

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Sep 2011Jul 2030

Study Start

First participant enrolled

September 1, 2011

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2030

Expected
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

10.9 years

First QC Date

July 19, 2020

Last Update Submit

July 28, 2020

Conditions

Breast Cancer

Keywords

Systemic relapsetherapeutic drug monitoring tamoxifenTumor microenvironmentAdipose stromal immune cell infiltrationTumor - adipose cell InteractionInvasive frontQoLSide effectsAdherence of TamoxifenFatigueWork Life Participation

Outcome Measures

Primary Outcomes (3)

  • Relapse Free Survival

    Time from operation to relapse of all types

    0-10 years

  • Breast Cancer specific Survival

    Time from operation to death due to Breast Cancer

    0-10 years

  • Overall Survival

    Time from operation to death due to all causes

    0-10 years

Secondary Outcomes (4)

  • Fatigue

    0 - 10 years

  • Work life participation

    0-3 years

  • Adherence to endocrine treatment

    0-10 years

  • Discontinuation of taking endocrine treatment

    0-10 years

Study Arms (1)

Early Stage Breast Cancer (Stage I and II)

Consecutive early stage breast cancer patients who are treated according to the national guidelines. Observation over 11 years.

Procedure: Breast Concervative or Meastectomy

Interventions

Breast Concervative or MeastectomyPROCEDURE

National treatment guidelines in Norway

Also known as: Radiation, Chemotherapy, Anti-estrogen treatment, Anti HER-2 treatment, Zoledronic acid
Early Stage Breast Cancer (Stage I and II)

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast Cancer is 100 x more frequent in female than in male
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women in the catchment area of Haukeland University Hospital (Bergen) and Stavanger University Hospital (Stavanger) in Western Norway

You may qualify if:

  • Early stage Breast Cancer
  • DCIS gr III

You may not qualify if:

  • Not able to read Norwegian
  • Not able to communicate in Norwegian
  • Previously diagnosed with cancer
  • Dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helse Stavanger HF

Stavanger, Rogaland, 4068, Norway

Location

Helse Bergen HF

Bergen, Vestland, 5021, Norway

Location

Related Publications (1)

  • Soiland H, Janssen EAM, Helland T, Eliassen FM, Hagland M, Nordgard O, Lunde S, Lende TH, Sagen JV, Tjensvoll K, Gilje B, Jonsdottir K, Gudlaugsson E, Lode K, Hagen KB, Gripsrud BH, Lind R, Heie A, Aas T, Austdal M, Egeland NG, Bernklev T, Lash TL, Skartveit L, Kroksveen AC, Oltedal S, Kvaloy JT, Lien EA, Sleire L, Mellgren G; PBCB-study group. Liquid biopsies and patient-reported outcome measures for integrative monitoring of patients with early-stage breast cancer: a study protocol for the longitudinal observational Prospective Breast Cancer Biobanking (PBCB) study. BMJ Open. 2022 Apr 29;12(4):e054404. doi: 10.1136/bmjopen-2021-054404.

    PMID: 35487718DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

EDTA blood, CPT tube, Platelets (miRNA)

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Interventions

RadiationDrug TherapyZoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical PhenomenaTherapeuticsDiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gunnar Mellgren, PhD

    Helse Bergen HF; Haukeland University Hospital

    STUDY DIRECTOR

  • Håvard Søiland, PhD

    Helse Stavanger HF; Stavanger University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Breast Cancer Surgery / Professor dr. med.

Study Record Dates

First Submitted

July 19, 2020

First Posted

July 28, 2020

Study Start

September 1, 2011

Primary Completion

July 15, 2022

Study Completion (Estimated)

July 15, 2030

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

NO(2)