Breast cancer in Ethiopia

Breast Cancer in Ethiopia - Biology, Genetics and Innovation

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN88484239

Enrollment

320

Registered

2023-08-31

Start date

2022-03-01

Completion date

Unknown

Last updated

2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer Cancer

Interventions

Study 1. 200 patients with breast cancer will be included in the study – 100 in Ethiopia (from Tikur Anbessa University Hospital) and 100 in Sweden (from SÖS general hospital). The patients are women

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with breast cancer, women 18-39 years and men 18 years and above. 2. First degree relatives (female) of the above patients. 3. Health care workers.

Exclusion criteria

Exclusion criteria: 1. Women 40 years and above 2. Non-malignant breast tumour 3. Inability or unwillingness to give informed consent

Design outcomes

Primary

Measure	Time frame
Occurrence of pathogenic variants predisposing for breast cancer in patients with breast cancer (women 18 - 39 years and men above 18 years) measured using DNA extracted from blood at inclusion or earliest convenient time point (early in study).	—

Secondary

Measure	Time frame
1. Occurrence of pathogenic variants predisposing for breast cancer in first degree relatives of patients with breast cancer and who are confirmed carriers of such pathogenic variants (ie positive cases for the primary outcome measure) measured using DNA extracted from blood at inclusion or earliest convenient time point (early in study). It's difficult to say exactly when it will be done. First the 100 index patients need to be included in the study and their analyses done. We expect to have these results in late 2023. 2. Knowledge, attitudes and perceptions of genetic testing for pathogenic variants predisposing for breast cancer in patients with breast cancer, their first degree relatives and health care workers measured using qualitative interview at inclusion in the study and no further data collection after that is planned. 3. Tumour biology and molecular subtype of breast cancer in women 18 - 39 years and men 18 years and above measured by analysis on breast cancer tissue at inclusion or earliest convenient time point (early in study). It's difficult to say exactly when it is done as it includes a combination of core needle biopsy done early on and resected tumour during surgery. Timing of surgery is hard to predict. We expect to have collected all tissues by 2023. 4. Outcomes of breast cancer in women 18 - 39 years and men 18 years and above measured by questionnaire based interviews with patients, contact over phone potentially with next of kin for patients who have died, patient files at the hospital at one year after inclusion in the study. 5. Adherence to recommended treatment and therapies among women 18 - 39 years and men 18 years and above with breast cancer measured using questionnaire based interviews with patients, contact over phone potentially with next of kin for patients who have died, patient files at the hospital at one year after inclusion in the study.	—

Measure

Time frame

1. Occurrence of pathogenic variants predisposing for breast cancer in first degree relatives of patients with breast cancer and who are confirmed carriers of such pathogenic variants (ie positive cases for the primary outcome measure) measured using DNA extracted from blood at inclusion or earliest convenient time point (early in study). It's difficult to say exactly when it will be done. First the 100 index patients need to be included in the study and their analyses done. We expect to have these results in late 2023. 2. Knowledge, attitudes and perceptions of genetic testing for pathogenic variants predisposing for breast cancer in patients with breast cancer, their first degree relatives and health care workers measured using qualitative interview at inclusion in the study and no further data collection after that is planned. 3. Tumour biology and molecular subtype of breast cancer in women 18 - 39 years and men 18 years and above measured by analysis on breast cancer tissue at inclusion or earliest convenient time point (early in study). It's difficult to say exactly when it is done as it includes a combination of core needle biopsy done early on and resected tumour during surgery. Timing of surgery is hard to predict. We expect to have collected all tissues by 2023. 4. Outcomes of breast cancer in women 18 - 39 years and men 18 years and above measured by questionnaire based interviews with patients, contact over phone potentially with next of kin for patients who have died, patient files at the hospital at one year after inclusion in the study. 5. Adherence to recommended treatment and therapies among women 18 - 39 years and men 18 years and above with breast cancer measured using questionnaire based interviews with patients, contact over phone potentially with next of kin for patients who have died, patient files at the hospital at one year after inclusion in the study.

—

Countries

Ethiopia, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026