NCT00836186

Cytokine Expression During Radiation for Breast Cancer

Completed NA Results posted Last updated 8 October 2020

What this trial tests

NA trial testing Radiation therapy in Breast Cancer in 82 participants. Completed in 1 November 2019.

Timeline

13 November 2009

Primary endpoint
26 November 2014

1 November 2019

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	82
Start date	13 November 2009
Primary completion	26 November 2014
Estimated completion	1 November 2019
Sites	2 locations across United States

Drugs / interventions tested

• Radiation therapy — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

Adults 18 to 100, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Proteins Expressed Differently in Response to Receiving Radiation Therapy Primary · 2 - 4 weeks post radiation therapy

Number of proteins that are expressed differently in response to receiving radiation therapy for breast cancer. The data reflect the total number of proteins pooled across all participants.

Group	Value	95% CI
Radiation Therapy	31

Number of Proteins With Differential Expression by Race/Ethnicity Secondary · 2 - 4 weeks post radiation therapy

To asses the impact of race/ethnicity on the expression of proteins after radiation therapy for breast cancer. The data reflect the total number of proteins pooled across all participants.

Group	Value	95% CI
Radiation Therapy	4

Number of Metabolites That Changed Differentially on the Basis of Patient Toxicity Secondary · 2 - 4 weeks post radiation therapy

The chemo/cytokine expression changes with respect to radiation toxicities as assessed by number of metabolites that changed differentially on the basis of patient toxicity. The data reflect the total number of metabolites pooled across all participants.

Group	Value	95% CI
Radiation Therapy	39

Sponsor's own description

To assess the magnitude and frequency of changes in chemo/cytokine expression in women receiving radiation treatment. To asses the impact of race/ethnicity on the magnitude and frequency of changes in chemo/cytokine expression during radiation therapy for breast cancer. And finally to assess the interaction between radiation-induced chemo/cytokine expression changes, and race/ethnicity, with respect to normal tissue reactions to radiation and tumor-associated outcomes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Multifaceted role of redox pattern in the tumor immune microenvironment regarding autophagy and apoptosis.
   Ren Y, Wang R, Weng S, Xu H, et al · · 2023 · cited 87× · PMID 37563639 · DOI 10.1186/s12943-023-01831-w