NCT06827132

Brief Summary

A multinational observational study to evaluate the current pathology practices and the utilization of computational pathology plus artificial intelligence algorithms in patients with suspected lung and breast cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress36%
Oct 2025May 2027

First Submitted

Initial submission to the registry

January 28, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

October 25, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

January 28, 2025

Last Update Submit

March 20, 2026

Conditions

Lung CancerBreast Cancer

Keywords

Artificial intelligenceComputational PathologyAlgorithmPositive predictive valueNegative predictive valueGalen™ Breast applicationMindPeak GmBHLaboratories

Outcome Measures

Primary Outcomes (3)

  • primary objective

    The duration between the biopsy-taken date/time and the biopsy-based pathological diagnosis date/time will be calculated based on the laboratory records retrospectively.

    2 years

  • Primary Objective

    Reading time to assess section slides for pathological diagnosis will also be extracted from the laboratory records, if relevant information was kept in the records.

    2 years

  • exploratory objective

    the total cost and fees related to training, for implementing digital pathology and computational AI pathology algorithms will be assessed as an endpoint.

    2 years

Secondary Outcomes (2)

  • secondary objectives

    2 years

  • exploratory objective

    2 years

Other Outcomes (4)

  • Secondary Objective

    2 years

  • Secondary Objective

    2 years

  • exploratory objective

    2 years

  • +1 more other outcomes

Eligibility Criteria

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

Data from samples that meet the following inclusion criterion will be analyzed. • Sample from adult patients (≥ 18 years) with suspected non-small cell lung cancer or invasive breast cancer or ductal carcinoma in situ.

You may not qualify if:

  • Samples with the inadequate technical quality of slides (pre-analytics quality) or images, e.g., broken slides, large out-of-focus areas, slides with fixation artefacts.
  • Samples from cases that were included in the training or technical validation.
  • Sample taken by fine needle aspiration.
  • Sample sent for cytological evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Nairobi, Kenya

RECRUITING

MeSH Terms

Conditions

Lung NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479information.center@astrazeneca.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 14, 2025

Study Start

October 25, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

KE(1)