Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research

November 20, 2023 updated by: Sanguine Biosciences
The study objective is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with active lung cancer to investigate the immune response to develop treatments and therapies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • Sanguine Biosciences
        • Principal Investigator:
          • Houman Hemmati, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will enroll up to 200 participants. Recruitment will occur through Sanguine advertisements, partnerships with cancer foundations, and cancer centers. Participants may be contacted for future studies.

Description

Inclusion Criteria:

  • Participants willing and able to provide written informed consent
  • Participants are willing and able to provide appropriate photo identification
  • Participant's age 18 - 100 years old
  • Participants diagnosed with active non-small cell lung cancer (Adenocarcinoma or Squamous Cell only. All stages are acceptable.)
  • Participants must have associated tissue biomarker data (EFGR and MET mutations) in their medical records

Exclusion Criteria:

  • Participants who are pregnant or nursing
  • Participants with a known history of HIV, hepatitis, or other infectious diseases
  • Participants who have taken an investigational product in the last 30 days
  • Participants who have experienced excess blood loss, including blood donation defined as 250 mL in the last month or 500 mL in the previous two months
  • Participants currently enrolled in a clinical trial
  • Participants currently in remission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biospecimen & Clinical Data Collection
Time Frame: 10 years

The primary objective is to collect 2000 whole blood samples from subjects who are diagnosed with active lung cancer.

The purpose of this study is to collect biospecimen samples (e.g., whole blood) from participants diagnosed with various active lung cancers so that investigations can analyze how the immune response can take place, and aid in understanding active lung cancer biomarkers for future early diagnosis and treatment options.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanguine Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2022

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

December 13, 2022

First Submitted That Met QC Criteria

December 28, 2022

First Posted (Actual)

December 30, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAN-08877

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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