NCT06686602

Brief Summary

This study will identify risk factors for oral mucositis/stomatitis and ocular surface events (OSE) in patients with advanced/metastatic non-small cell lung cancer (NSCLC) and advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,759

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

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

July 9, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

November 11, 2024

Last Update Submit

March 18, 2025

Conditions

Advanced/Metastatic NSCLCAdvanced/Metastatic HER2-negative Breast Cancer

Keywords

Advanced/metastatic non-small cell lung cancer (NSCLC)Advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancerOral mucositis/stomatitisOcular surface events

Outcome Measures

Primary Outcomes (2)

  • Patient Demographics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE

    From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)

  • Clinical Characteristics in NSCLC and Breast Cancer Patients With Oral Mucositis/Stomatitis or OSE Compared with Patients Without Oral Mucositis/Stomatitis or OSE

    From NSCLC diagnosis (01 January 2015) or Breast Cancer diagnosis (01 January 2012) up to until death, exit from the database, or March 31, 2024, whichever comes first (approximately 12 years 2 months)

Study Arms (2)

NSCLC

Adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) non-small cell lung cancer (NSCLC).

Other: No drug

HER2-negative Breast Cancer

Adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC or IV) human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Other: No drug

Interventions

No drugOTHER

This is a non-interventional study and no study drug will be administered.

HER2-negative Breast CancerNSCLC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This nested case-control study is conducted in cohorts of adult patients diagnosed with advanced or metastatic (stage IIIB/IIIC, or IV) NSCLC and advanced or metastatic HER2-negative breast cancer. The time period is 2015 to 2023 for the NSCLC cohort and 2012 to 2023 for the breast cancer cohort. This time period was selected to account for the post-immunotherapy era for NSCLC and post-everolimus era for breast cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ConcertAI Database

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungStomatitis

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesMouth DiseasesStomatognathic Diseases

Study Design

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

Study Record Dates

First Submitted

November 11, 2024

First Posted

November 13, 2024

Study Start

July 9, 2024

Primary Completion

December 16, 2024

Study Completion

March 18, 2025

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)