Assessing determinants of breast cancer patients in Indonesia for delayed diagnosis, treatment, risks of relapse, and survival
| ISRCTN | ISRCTN13788093 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13788093 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | INABrC01 |
| Sponsor | Universitas Gadjah Mada |
| Funders | Universitas Gadjah Mada, NUS-UGM-Tahir Foundation |
- Submission date
- 29/09/2020
- Registration date
- 02/10/2020
- Last edited
- 08/06/2022
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
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 2026
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
Contact information
Public
Department of Surgery
Dr Sardjito Hospital/Faculty of Medicine
Universitas Gadjah Mada
Jl. Kesehatan 01
Yogyakarta
55281
Indonesia
 ORCID ID |
0000-0002-2607-6682 |
|---|---|
| Phone | +62-274-581333 |
| sl.anwar@ugm.ac.id |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Assessing demographic, social, clinical, and pathological determinants of breast cancer patients for delayed diagnosis, treatment, risks of relapse, and survival |
| Study acronym | INABrC |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Overall survival at the end of the study measured using patient records |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 2000 |
| Key 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 |
| Key exclusion criteria | 1. Vulnerable breast cancer patients |
| Date of first enrolment | 06/04/2018 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- Indonesia
Study participating centre
Jl Kesehatan No 1
Yogyakarta
55281
Indonesia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/06/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2022 to 30/06/2026.
2. The overall trial end date has been changed from 31/12/2022 to 31/12/2026 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/12/2023 to 01/12/2026.
02/10/2020: Trial’s existence confirmed by Universitas Gadjah Mada Yogyakarta
