Colorectal CancerNCT03517332
Circulating Tumor DNA Exposure in Peripheral Blood
An observational study of Colorectal Cancer and Pancreatic Adenocarcinoma, run by Quantgene Inc. at 6 sites in 2 countries.
Trial summary
This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer
- Type of treatment
- Injection or infusion
- How many people
- 10,000 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 1 Jan 2015to 31 Dec 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: * Subjects that are diagnosed with a malignancy (cohort 1) * Subjects that have not been diagnosed with a malignancy (cohort 2)
Who may be able to join
- This study will include subjects that are diagnosed with a malignancy (cohort
- 1) and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).
- Subjects of both cohorts must:
- Be of age ≥ 18
- Provide written consent for study participation
- Subject of cohort 1 must:
Show all 9Show fewer
- Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma
- Subjects of cohort 2 must:
- Meet the listed matching criteria
Who cannot join
- Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy
- Subjects of cohort 2 must not:
- Have been diagnosed/treated for a malignancy previously
Trial locations and contacts
6 sites in 2 countries.
Monika Hagen, M.D. contact
6 sites in 2 countries
United States5 sites, 4 recruiting
- Recruiting
Florida Hospital Celebration Health
Celebration, Florida, 34747
Lorraine Hickson, MRA
Olga Ivanov, MD
- Recruiting
Premier Surgical Oncology
Centerville, Ohio, 45459
James Ouellette, D.O.
James Ouellette, D.O
- Recruiting
Kettering Medical Center
Dayton, Ohio, 45429
Molly Regan
Minia Hellan, M.D.
- Recruiting
Orlando Health UF Health Cancer Center
Orlando, Florida, 32806
Vernique Walker
Debashish Bose, MD, PhD
- Active, not recruiting
University of Arizona Cancer Center
Tucson, Arizona, 85724
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva
Geneva
Pamela Sun, M.D.
Frederic Ris, M.D.
About this study
Official title: Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study
This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).
Read the detailed description
This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the following: Demographics, Tumor Characteristics, Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical information, and Follow-up at intermittent future time points, for up to 15 years. The study test(s) to be used in this protocol is a multiplexed primer and probe design developed, that allows detecting a wider set of mutations at a higher sensitivity then conventional sequencing-based method. This novel process is currently being investigated at Quantgene Inc.
- Conditions
- Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Bladder Cancer
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung, Urinary Bladder Neoplasms, Melanoma, Ovarian Neoplasms, Adrenal Cortex Neoplasms
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 |
|---|---|---|
| Cohort 1 | Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma Subjects of cohort 1 must not: • Have been treated for above diagnosed malignancy | |
| Cohort 2 | Negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2). Subjects of cohort 2 must: • Meet the listed matching criteria Subjects of cohort 2 must not: • Have been diagnosed/treated for a malignancy previously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study
The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).
Measured: 28 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start1 Jan 2015
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quantgene Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517332
- Sponsor's protocol ID
- QG01012015
- Status last verified
- Nov 2018
- First submitted
- 24 Apr 2018
- Last updated
- 20 Nov 2018
- 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 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA Exposure in Peripheral Blood Using a Novel Process: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03517332
- Acronym / sponsor ID
- QG01012015
- Conditions
- Colorectal Cancer, Pancreatic Adenocarcinoma, Gastric Cancer, Hepatocellular Carcinoma, Non-small Cell Lung Cancer, Bladder Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Quantgene Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 7 May 2018 (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.
This is a prospective, multi-center, blinded feasibility study. The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).
Detailed description
This prospective, multi-center, feasibility study represents a feasibility study to determine the potential of circulating tumor DNA exposure in peripheral blood using a novel process in a sample of patients with different types of malignant organ tumors and a control cohort without malignant disease. The study applies a new process to detect ctDNA and other molecular markers in peripheral blood using: a collection of de-identified blood specimen and clinical data from up to 10,000 participants from clinical sites across the United States and Europe. Data collected will include the following: Demographics, Tumor Characteristics, Information about Treatment, Specimen Assessment, Postoperative Assessment Clinical information, and Follow-up at intermittent future time points, for up to 15 years. The study test(s) to be used in this protocol is a multiplexed primer and probe design developed, that allows detecting a wider set of mutations at a higher sensitivity then conventional sequencing-based method. This novel process is currently being investigated at Quantgene Inc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Have a diagnosis of a malignancy in clinical stage 0 to IV including but not limited to: colon or rectal cancer, pancreatic and gastric cancer, hepatocellular carcinoma, non-small cell lung cancer, bladder cancer, melanoma Subjects of cohort 1 must not: • Have been treated for above diagnosed malignancy |
| Cohort 2 | – | –Negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2). Subjects of cohort 2 must: • Meet the listed matching criteria Subjects of cohort 2 must not: • Have been diagnosed/treated for a malignancy previously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Subjects that are diagnosed with a malignancy (cohort 1) * Subjects that have not been diagnosed with a malignancy (cohort 2)
Key inclusion criteria (9 listed)
- This study will include subjects that are diagnosed with a malignancy (cohort
- 1) and a negative cohort with subjects that have not been diagnosed with a malignancy (cohort 2).
- Subjects of both cohorts must:
- Subject of cohort 1 must:
- Meet the listed matching criteria
Key exclusion criteria (3 listed)
- Subjects of cohort 1 must not: Have been treated for above diagnosed malignancy
- Subjects of cohort 2 must not:
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
Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study
Time frame: 28 Months
The objective of this study is to test the feasibility of the detection of tumor DNA of a variety of tumors in peripheral blood using a novel process for the detection of circulating tumor DNA (ctDNA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
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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.
Monika Hagen, M.D. contact
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Pancreatic Adenocarcinoma, run by Quantgene Inc. at 6 sites in 2 countries.
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 9 inclusion and 3 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 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Switzerland. 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 Monika Hagen, M.D. (mh@quantgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor DNA exposure in peripheral blood using a novel process: A feasibility study (time frame: 28 Months). 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 20 Nov 2018.