CancerNCT02288754
Detection of Tumor DNA in Blood Samples From Cancer Patients
An observational study of Cancer and Tumors, run by Lexent Bio, Inc. at 1 site in United States.
Trial summary
The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Blood test
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Nov 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are (i) commencing or (ii) starting a new line of treatment for metastatic disease with any cytotoxic chemotherapy, targeted therapy, immunotherapy, a combination of any and/or radiation therapy. Patients with stage II or III solid tumors undergoing curative intend surgery or neoadjuvant therapy followed by surgery are also eligible, before surgery or initiation of neoadjuvant therapy.
Who may be able to join
- Age 18 years or older
- Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery
- Starting treatment or a new line of treatment
- Able to understand and grant informed consent
- Able to have their blood drawn
Who cannot join
- Unable to grant informed consent or comply with all study procedures.
- Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cancer Care Associates
Torrance, California, 90277
David Chan, MD, 310-750-3300
About this study
Official title: Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and "Healthy Controls"
The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
- Being tested
- Blood test
- Keywords
- DNA in Tumors, cfDNA, WGS, Advanced stage cancer, Solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
No intervention except to collect blood for diagnostic test development
| Study group | Role | What they receive |
|---|---|---|
| Stage II or III curative surgery (closed to accrual) | Patients with stage II or III solid tumors undergoing curative intend surgery enrolled before surgery. Receives: Diagnostic Test: Blood test | |
| Stage II or III neoadjuvant therapy cohort (closed to accrual) | Patients with stage II or III solid tumors undergoing neoadjuvant therapy followed by curative intend surgery enrolled before neoadjuvant therapy. Receives: Diagnostic Test: Blood test | |
| Metastatic disease | Patients with advanced, recurrent and/or metastatic disease requiring systemic therapy with chemotherapy, targeted therapy, immunotherapy or a combination of any before initiation of any therapy or a new line of therapy following documentation of disease progression on prior therapy. Receives: Diagnostic Test: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the tumor load score and patient response to therapies.
Determination of a direct correlation between the tumor load score and patient response to therapies.
Measured: 5 years
Secondary outcomes (1)
Determination of particular mutation events which underlie the basis of any established correlation with therapy response.
To determine which particular mutation events underlie the basis of any established correlation with therapy response.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionNov 2019 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lexent Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Haluk Tezcan, MD, Principal investigator, Lexent Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288754
- Sponsor's protocol ID
- LB1985106
- Status last verified
- Aug 2019
- First submitted
- 7 Nov 2014
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Tumor DNA in Blood Samples From Patients With Late Stage Cancer and "Healthy Controls"
- ClinicalTrials.gov ID
- NCT02288754
- Acronym / sponsor ID
- LB1985106
- Keywords
- DNA in Tumors, cfDNA, WGS, Advanced stage cancer, Solid tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lexent Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 11 Nov 2014 (estimated)
- 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 aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor nucleic acids in the blood of a cancer patient with diagnosed metastatic disease that is either commencing, currently undergoing or completed cytotoxic chemotherapy treatment. More generally, this approach will allow us to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage II or III curative surgery (closed to accrual) | – | Diagnostic Test: Blood testPatients with stage II or III solid tumors undergoing curative intend surgery enrolled before surgery. |
| Stage II or III neoadjuvant therapy cohort (closed to accrual) | – | Diagnostic Test: Blood testPatients with stage II or III solid tumors undergoing neoadjuvant therapy followed by curative intend surgery enrolled before neoadjuvant therapy. |
| Metastatic disease | – | Diagnostic Test: Blood testPatients with advanced, recurrent and/or metastatic disease requiring systemic therapy with chemotherapy, targeted therapy, immunotherapy or a combination of any before initiation of any therapy or a new line of therapy following documentation of disease progression on prior therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are (i) commencing or (ii) starting a new line of treatment for metastatic disease with any cytotoxic chemotherapy, targeted therapy, immunotherapy, a combination of any and/or radiation therapy. Patients with stage II or III solid tumors undergoing curative intend surgery or neoadjuvant therapy followed by surgery are also eligible, before surgery or initiation of neoadjuvant therapy.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Have metastatic disease with from a solid tumor (e.g. breast, lung, colon, pancreas, ovary, prostate...) or stage II or III solid tumors undergoing curative surgery or neoadjuvant therapy followed by surgery
- Starting treatment or a new line of treatment
- Able to understand and grant informed consent
- Able to have their blood drawn
Key exclusion criteria (2 listed)
- Unable to grant informed consent or comply with all study procedures.
- Has a hematological malignancy, i.e. myeloma, lymphoma, MDS, leukemia
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 |
|---|---|---|
| Blood testNo intervention except to collect blood for diagnostic test development | Diagnostic test | Metastatic disease, Stage II or III curative surgery (closed to accrual), Stage II or III neoadjuvant therapy cohort (closed to accrual) |
Primary outcome
Correlation between the tumor load score and patient response to therapies.
Time frame: 5 years
Determination of a direct correlation between the tumor load score and patient response to therapies.
1 secondary outcome
Determination of particular mutation events which underlie the basis of any established correlation with therapy response.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Haluk Tezcan, MD principal investigator
Lexent Bio
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 Cancer and Tumors, run by Lexent Bio, Inc. 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 2 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 14 Aug 2019. 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 Haluk Tezcan, MD (530-863-7922, htezcan@lexentbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the tumor load score and patient response to therapies. (time frame: 5 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 14 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.