Assessing the Impact of the Microbiome on Breast Cancer Radiotherapy Toxicity

NCT04245150 | Completed

• 1 other identifier: CASE5118
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Microorganisms in the human body (such as virus, bacteria, fungus) may have an important role in breast cancer side effects. In this study, microorganisms will be analyzed to determine which, if any,are present. It will then be determined if side effects from breast radiation are associated with these microorganisms. Understanding the association of microorganisms with side effects will allow the study team to look at strategies to reduce side effects for patients undergoing radiation to the breast.

Conditions

DCIS; Invasive Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Microbiome profile as assessed by stool sample

  Microbiome profile as assessed by stool sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample

  At baseline

• Microbiome profile as assessed by breast skin sample

  Microbiome profile as assessed by breast skin sample. Sample analysis will be done via DNA extraction and rRNA gene sequencing of stool sample

  At baseline

• Correlation of the microbiome to incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring

  The microbiome profiles identified will be correlated with incidence of at least grade 3 skin toxicity using the CTCAE version 4.0 scoring by visual assessment. Maximum toxicity during radiation will be recorded. Grade 0: None Grade 1: Faint erythema or dry desquamation Grade 2: Moderate to brisk erythema; patchy moist desquamation, mostly confined to skin folds and creases; moderate edema Grade 3: Moist desquamation in areas other than skin folds and creases; bleeding induced by minor trauma or abrasion Grade 4: Life-threatening consequences; skin necrosis or ulceration of full thickness dermis; spontaneous bleeding from involved site; skin graft indicated

  3 months post-treatment

Study Arms (1)

Ductal Carcinoma In Situ (DCIS) or invasive breast cancer

Participants with DCIS or invasive breast cancer

Other: Stool sample; Other: Skin Swab Sample

Interventions

Stool sample OTHER

Stool sample

Ductal Carcinoma In Situ (DCIS) or invasive breast cancer

Skin Swab Sample OTHER

Skin Swab Sample

Ductal Carcinoma In Situ (DCIS) or invasive breast cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with biopsy proven DCIS or invasive breast cancer, 18 years of age or older, undergoing breast conserving surgery and adjuvant radiation therapy at Cleveland Clinic.

You may qualify if:

• Breast cancer patients with DCIS or invasive breast cancer
• Undergoing breast conserving surgery and adjuvant radiation
• Subjects must be willing and able to provide breast skin samples

You may not qualify if:

• Active clinical breast infection (on antiobiotic for skin/breast infection or clinical diagnosis)
• Refuse or are unable to sign informed consent form
• Past history of breast cancer

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Breast skin and GI samples from participants with breast cancer following breast conserving surgery will be collected. These samples will then be analyzed using DNA extraction and 16S rRNA gene sequencing with an in-house bioinformatics group. Data will be used to define the microbiome profile for this subset of breast cancer patients.

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Chirag Shah, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 28, 2020
• Study Start: March 21, 2019
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)