CompletedNot applicableNCT03688347
Official study title

Microbiome in Lung Cancer and Other Malignancies

Study summary

To characterize the fecal, skin, nasal and oral microbiome and metabolome in patients with lung cancer and other malignancies, and correlate to treatment response and toxicities of various therapies including immunotherapy, chemotherapy and targeted therapy, etc.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNasal Swab and Oral Swab

Plus 4 other study approaches.

Who it may be forLung Cancer · Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 11, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Taher Abu Hejleh

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Taher Abu Hejleh
Interventions being studied
Procedure: Nasal Swab; Procedure: Oral Swab; Other: Stool Collection; Genetic: Microbiome analysis; Genetic: DNA Banking; Procedure: Skin Swab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Patients diagnosed with lung cancer and other malignancies who are candidates for systemic therapies such as immunotherapy and chemotherapy Eligibility criteria for studying microbiome in patients receiving immunotherapy:
  • Patients with advanced/recurrent lung cancer (including both NSCLC and SCLC) and other solid tumors of our study interest (e.g. GU cancer and melanoma, etc.) that initiate a new line of immunotherapy (can be 1st or later line), either alone or in combination with chemotherapy, targeted therapy or other immunotherapy.
  • Patients can be in other clinical trials as long as they meet criteria 1.
  • Prior treatment with immunotherapy is acceptable as long as criteria 1 is met. For example, a new line therapy with pembrolizumab plus pemetrexed after failing pembrolizumab is considered eligible.
  • Patients who are to start immunotherapy maintenance after chemoradiation therapy are eligible (e.g. NSCLC patients who will be on durvalumab maintenance)
  • Patients who are to start immunotherapy after local therapies (e.g. radiation, ablation, etc.) are eligible.
  • Immunotherapy must have component of anti-PD-1/PD-L1 agents (e.g. nivolumab, pembrolizumab, atezolizumab, durvalumab and avelumab, etc.) or anti-CTLA4 (e.g. ipilimumab)
Reasons someone may not be able to joinExclusion criteria
  • Patients \< 18 years of age
  • Patients that are pregnant
  • Patients taking more than 2 alcoholic drinks per day and those using non-medical drugs such as marijuana, cocaine, heroine, etc.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Iowa Hospitals and ClinicsIowa City, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 11, 2022. Always confirm current availability with the study team.

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