NCT06026176

Brief Summary

Research Title PATTERN OF CLINICAL PRESENTATION OF DIFFERENT BREAST DISEASE IN SURGICAL OPD AT BPKIHS Rationale: The Study will help us to know about pattern of presentation of different breast diseases Aims and Objectives:

  1. 1.To investigate the pattern of symptoms in patients with Breast diseases
  2. 2.To assess the burden of different Breast diseases. Research Hypothesis (if relevant): N/A
  3. 3.Whether study involves Human/animals or both : Human
  4. 4.Population/ participants: Files of patients presenting in Surgical OPD with Breast related complaints
  5. 5.Type of study design: : Descriptive Research Design
  6. 6.Human study :
  7. 7.Expected sample size : 823 Sample size calculation: Mentioned in methodology
  8. 8.Control groups : N/A
  9. 9.Probable duration of study: 365 days
  10. 10.Setting: Outpatient Department
  11. 11.Parameter/Variables to be applied/measured Independent Variables i. Socio-demographic characteristics such as age, gender, address. ii. Family History
  12. 12.Other resources needed: No
  13. 13.For Intervention trial: Not applicable A. Permission from Drug Controller of Nepal required/ Not required/Received/ Applied when\_\_\_\_\_ B. Safety measure C. Plan to withdraw

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,023

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 6, 2023

Completed
Last Updated

September 6, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

August 18, 2023

Last Update Submit

September 4, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Clinical symptoms associated with breast disease

    One year

  • Type of breast disease (benign or malignant)

    One Year

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who presented to the surgical outpatient department (OPD) of a community-based tertiary care hospital in Nepal. These patients sought medical attention for various breast-related complaints over a one-year period. The population includes both male and female individuals.

You may qualify if:

  • Patients presenting in Surgical OPD with Breast and related complaints

You may not qualify if:

  • Those who deny consent for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BPKIHS

Dharān, Koshi, Nepal

Location

MeSH Terms

Conditions

Breast DiseasesBreast NeoplasmsMastodyniaFibroadenoma

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesNeoplasms by SiteNeoplasmsPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms, Glandular and Epithelial

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 18, 2023

First Posted

September 6, 2023

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

September 6, 2023

Record last verified: 2023-09

Locations