Condition category
Cancer
Date applied
29/09/2020
Date assigned
02/10/2020
Last edited
02/10/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Breast cancer is the most common cancer among women worldwide including in Indonesia. The death rates of breast cancer patients are significantly higher in developing countries including in Indonesia in comparison those in developed nations. The aim of this study is to collect a variety of data from patients diagnosed with breast cancer in order to define specific characteristics and recurrence rates, progression, and overall survival in breast cancer patients.

Who can participate?
Patients aged over 18 years old with a diagnosis of breast cancer from 2014 to 2022

What does the study involve?
The study involves collecting information on the risk factors, course of the disease, the response to different treatments, recurrence rates, progression, and death from cancer. There is an optional choice to provide a number of blood or tissue samples for the duration of diagnosis, treatment, and follow-up.

What are the possible benefits and risks of participating?
There are no specific risks or benefits to participants.

Where is the study run from?
Universitas Gadjah Mada / Dr Sardjito Hospital, Yogyakarta (Indonesia)

When is the study starting and how long is it expected to run for?
January 2018 to December 2022

Who is funding the study?
Universitas Gadjah Mada (Indonesia)

Who is the main contact?
1. Dr Sumadi Lukman Anwar
sl.anwar@ugm.ac.id
2. Prof. Dr. Teguh Aryandono
teguharyandono@yahoo.com

Trial website

Contact information

Type

Public

Primary contact

Dr Sumadi Lukman Anwar

ORCID ID

https://orcid.org/0000-0002-2607-6682

Contact details

Department of Surgery
Dr Sardjito Hospital/Faculty of Medicine
Universitas Gadjah Mada
Jl. Kesehatan 01
Yogyakarta
55281
Indonesia
+62-274-581333
sl.anwar@ugm.ac.id

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

INABrC01

Study information

Scientific title

Assessing demographic, social, clinical, and pathological determinants of breast cancer patients for delayed diagnosis, treatment, risks of relapse, and survival

Acronym

INABrC

Study hypothesis

Demographic, social, clinical, and pathological determinants are associated with delayed diagnosis, risks of relapse, and survival of breast cancer diagnosed and treated according to the local and national guidelines in Indonesia

Ethics approval

Approved 20/10/2017, Ethics Committee of the Faculty of Medicine, Public Health, and Nursing (Universitas Gadjah Mada Yogyakarta, Jl Farmako Sekip Utara - Gedung Radiopetro 2nd Floor, Yogyakarta 55281, India; +62-274-588688-17225; mhrec_fmugm@ugm.ac.id), ref: 1143/EC/2017

Study design

Observational cohort

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Sociodemographic and clinicopathological determinants in breast cancer diagnosis and prognosis

Intervention

In this study, sociodemographic and clinicopathological variables will be collected and breast cancer patients will be followed-up for the locoregional recurrence, progression into distant metastasis, and survival.

The patient will be interviewed using a questionnaire (15-20 minutes to complete) to assess risks of breast cancer and general awareness of cancer and cancer screening. The patient will then be followed-up for minimum of 6 months. Medical records will be extracted to collect information of clinical and pathological variable including the follow-up examination according to the local clinical guidances (every 6 months examination of sonography, x-ray, and yearly mammography). A blood sample is optional if the patient agrees to donate for additional examination, 5-10 ml of whole blood will be taken and stored at the biobank.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Overall survival at the end of the study measured using patient records

Secondary outcome measures

1. Sociodemographic backgrounds, occupation, income, general understanding of cancer, and hormonal factors such as menarche, menopause, BMI, contraception, number of children, breastfeeding practice, and usage of hormonal replacement therapy measured using a novel questionnaire at baseline
2. Cancer progression into distant metastasis, defined as presence of cancer spread to the lung, bone, liver, and brain indicating with clinical manifestations and were confirmed with imaging/pathology examination and/or radiologic changes confirmed with computed tomography imaging with contrast or whole-body bone scan every 6 months after baseline
3. Other clinical findings revealed by thorough clinical examination and imaging conducted at routine follow up visits retrieved from patient records

Overall trial start date

06/01/2018

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Confirmed breast cancer according to the pathology report
2. Participants are able to provide written informed consent (over 18 years old)
3. No emergency procedure is required during the first presentation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2,000

Participant exclusion criteria

1. Vulnerable breast cancer patients

Recruitment start date

06/04/2018

Recruitment end date

30/06/2022

Locations

Countries of recruitment

Indonesia

Trial participating centre

Universitas Gadjah Mada
Dr Sardjito Hospital Jl Kesehatan No 1
Yogyakarta
55281
Indonesia

Sponsor information

Organisation

Universitas Gadjah Mada

Sponsor details

Faculty of Medicine
Jl Farmako
Sekip Utara
Yogyakarta
55281
Indonesia
+62-274-560300
fku@ugm.ac.id

Sponsor type

University/education

Website

https://fk.ugm.ac.id/en/

Funders

Funder type

University/education

Funder name

Universitas Gadjah Mada

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NUS-UGM-Tahir Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed international journal. Raw data without any identification of participants will be shared according to the WHO and ICMJE.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

01/12/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/10/2020: Trial’s existence confirmed by Universitas Gadjah Mada Yogyakarta