Non Small Cell Lung CancerNCT05669105
Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research
An observational study of Non Small Cell Lung Cancer, run by Sanguine Biosciences at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Specimen sample
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sanguine Biosciences
Waltham, Massachusetts, 02451
Thomas Goslin, 818-583-8844, tgoslin@sanguinebio.com
Houman Hemmati, MD
About this study
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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Specimen sample
- Keywords
- lung cancer, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen sampleDiagnostic test
Participants will have up to 100 mL of whole blood collected.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biospecimen & Clinical Data Collection
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start19 Feb 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanguine Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669105
- Sponsor's protocol ID
- SAN-08877
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Whole Blood From Active Non-Small Cell Lung Cancer Patients for Supplemental Research
- ClinicalTrials.gov ID
- NCT05669105
- Acronym / sponsor ID
- SAN-08877
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- lung cancer, NSCLC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sanguine BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen sampleParticipants will have up to 100 mL of whole blood collected. | Diagnostic test | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Sanguine Biosciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Goslin ((818) 583-8844, tgoslin@sanguinebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biospecimen & Clinical Data Collection (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.