Neoplasms, Non-hematologic - Stage I-IIINCT03071809
Detection of Tumor DNA in Blood Samples From Patients With Early Stage Cancer and "Healthy Controls"
An observational study of Neoplasms, Non-hematologic - Stage I-III, 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-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms, Non-hematologic - Stage I-III
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2017to 15 Mar 2019
- 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: Up to 200 patients from multiple clinical sites will be enrolled in this study. Patients are eligible for this study if they are diagnosed with a solid tumor and undergoing curative resection. In addition, up to 200 participants with no prior or current diagnosis of cancer will be enrolled as a control group, i.e. "healthy control," for assay development.
Who may be able to join
- 1. For all participants:
- Age 18 years or older
- Able to understand and grant informed consent
- Able to have their blood drawn at enrollment before surgery and 7 to 28 days after surgery
- For participants with early stage solid tumors:
- Diagnosed with an early stage (I-III) solid tumor with curative intent surgery without neoadjuvant therapy planned
- For "healthy control" subgroup:
- No prior or current diagnosis of any cancer. Participants with prior in situ cancer or non-melanoma skin cancer will be allowed to participate but will not be included in the "healthy control" cohort and will be analyzed separately.
Who cannot join
- Unable to grant informed consent or comply with all study procedures
- Diagnosed with a hematological malignancy (acute or chronic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myeloma or lymphoma).
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
Read the detailed description
The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
The presence of circulating tumor-derived cfDNA in the plasma of patients can potentially enable a non-invasive means of detecting the presence or absence of tumor, assessing tumor burden and characterizing tumor biology in patients with cancer. The ability to measure the distribution of circulating tumor DNA may allow determination of a quantitative tumor load score in plasma that correlates to clinical tumor load. Clinical tumor load is a measure of disease burden, and the investigators propose to test in this study whether the tumor load score can measure this disease burden. A simple, reliable measure of disease burden would have diverse utility during patient therapy.
- Conditions
- Neoplasms, Non-hematologic - Stage I-III
- Keywords
- Solid tumor, carcinoma, sarcoma, stage I, stage II, stage III
- Medical subject headings
- Neoplasms, Carcinoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early stage neoplasm | Patients with stage I-III early stage non-hematologic neoplasm | |
| Healthy Control | Patients undergoing surgery for a non-malignant condition with no prior history of malignancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of signal in the presence of active neoplasm
To determine the association between the tumor load score and clinical tumor load as assessed with the current standard of care methods and pathology findings.
Measured: 2 years
Determine change in signal after surgery
To determine the response of tumor load score as a function of tumor presence as determined pre- and post-surgery intended to be curative
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 posted7 Mar 2017
- Study start30 Jun 2017
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Why it stopped: Accrual difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, Non-hematologic - Stage I-IIIStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
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
- NCT03071809
- Sponsor's protocol ID
- LB-2017-03-01
- Status last verified
- Aug 2019
- First submitted
- 1 Mar 2017
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 Early Stage Cancer and "Healthy Controls"
- ClinicalTrials.gov ID
- NCT03071809
- Acronym / sponsor ID
- LB-2017-03-01
- Conditions
- Neoplasms, Non-hematologic - Stage I-III
- Keywords
- Solid tumor, carcinoma, sarcoma, stage I, stage II, stage III
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Accrual difficulties
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Lexent Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 7 Mar 2017 (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 aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
Detailed description
The aim of this study is to employ genomic detection methodologies to measure the relative amount of tumor-derived nucleic acids in the blood of patients diagnosed with an early stage solid tumor who are either commencing, currently undergoing or have completed treatment. This approach will allow the investigators to develop a quantitative measure of therapy efficacy via the counting of the relative changes in tumor molecules over the course of treatment.
The presence of circulating tumor-derived cfDNA in the plasma of patients can potentially enable a non-invasive means of detecting the presence or absence of tumor, assessing tumor burden and characterizing tumor biology in patients with cancer. The ability to measure the distribution of circulating tumor DNA may allow determination of a quantitative tumor load score in plasma that correlates to clinical tumor load. Clinical tumor load is a measure of disease burden, and the investigators propose to test in this study whether the tumor load score can measure this disease burden. A simple, reliable measure of disease burden would have diverse utility during patient therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early stage neoplasm | – | –Patients with stage I-III early stage non-hematologic neoplasm |
| Healthy Control | – | –Patients undergoing surgery for a non-malignant condition with no prior history of malignancy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 200 patients from multiple clinical sites will be enrolled in this study. Patients are eligible for this study if they are diagnosed with a solid tumor and undergoing curative resection. In addition, up to 200 participants with no prior or current diagnosis of cancer will be enrolled as a control group, i.e. "healthy control," for assay development.
Key inclusion criteria (8 listed)
- Age 18 years or older
- Able to understand and grant informed consent
- Able to have their blood drawn at enrollment before surgery and 7 to 28 days after surgery
- Diagnosed with an early stage (I-III) solid tumor with curative intent surgery without neoadjuvant therapy planned
- No prior or current diagnosis of any cancer. Participants with prior in situ cancer or non-melanoma skin cancer will be allowed to participate but will not be included in the "healthy control" cohort and will be analyzed separately.
Key exclusion criteria (2 listed)
- Unable to grant informed consent or comply with all study procedures
- Diagnosed with a hematological malignancy (acute or chronic leukemia, myelodysplastic syndrome, myeloproliferative neoplasm, myeloma or lymphoma).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of signal in the presence of active neoplasm
Time frame: 2 years
To determine the association between the tumor load score and clinical tumor load as assessed with the current standard of care methods and pathology findings.
Determine change in signal after surgery
Time frame: 5 years
To determine the response of tumor load score as a function of tumor presence as determined pre- and post-surgery intended to be curative
Results and safety
The study was stopped early (reason given: Accrual difficulties). 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 Neoplasms, Non-hematologic - Stage I-III, 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 8 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: stopped early, 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?
The study was stopped early (reason given: Accrual difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of signal in the presence of active neoplasm (time frame: 2 years). The study lists 2 primary outcomes in all. 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.