CTC and Tumor Related Rare CellNCT03434912
Identification and Evaluation of Circulating Tumor Cells and Tumor Related Rare Cells in Immunotherapy
An observational study of CTC and Tumor Related Rare Cell, run by MiCareo Taiwan Co., Ltd. at 1 site in Taiwan.
Trial summary
The primary objective of this study is designed to evaluate the enumeration of circulating tumor cells and identify the potential biomarkers associated with clinical outcome. The secondary objective is to explore whether the changes of tumor related rare cells associates clinical outcome. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- CTC and Tumor Related Rare Cell
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 May 2017to 30 Apr 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 80 cancer patients undergoing immunotherapy
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Over 20 years of age.
- Cancer patients on immune checkpoint inhibitors.
Who cannot join
- Subjects who have other cancer history
- Pregnant females
- Subjects with active, known or suspected autoimmune disease.
- Known history of human immunodeficiency virus (HIV)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
About this study
Official title: Identification and Evaluation of the Potential Biomarkers on Circulating Tumor Cells and Tumor Related Rare Cells in Cancer Patients Undergoing Immunotherapy
The primary objective of this study is designed to evaluate the enumeration of circulating tumor cells and identify the potential biomarkers associated with clinical outcome. The secondary objective is to explore whether the changes of tumor related rare cells associates clinical outcome.
- Conditions
- CTC and Tumor Related Rare Cell
- Medical subject headings
- Neoplastic Cells, Circulating
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating tumor cell
Isolation and analysis of circulating tumor cells before and after immunotherapy
Measured: 1 years
Secondary outcomes (1)
tumor related rare cell
Isolation and analysis of tumor related rare cells before and after immunotherapy
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start24 May 2017
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CTC and Tumor Related Rare CellStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MiCareo Taiwan Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434912
- Sponsor's protocol ID
- MiC-SRS-HNSCC-001
- Status last verified
- May 2018
- First submitted
- 7 Feb 2018
- Last updated
- 16 Aug 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 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Evaluation of the Potential Biomarkers on Circulating Tumor Cells and Tumor Related Rare Cells in Cancer Patients Undergoing Immunotherapy
- ClinicalTrials.gov ID
- NCT03434912
- Acronym / sponsor ID
- MiC-SRS-HNSCC-001
- Conditions
- CTC and Tumor Related Rare Cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- MiCareo Taiwan Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 24 May 2017 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 15 Feb 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.
The primary objective of this study is designed to evaluate the enumeration of circulating tumor cells and identify the potential biomarkers associated with clinical outcome. The secondary objective is to explore whether the changes of tumor related rare cells associates clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 80 cancer patients undergoing immunotherapy
Key inclusion criteria (3 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
- Over 20 years of age.
- Cancer patients on immune checkpoint inhibitors.
Key exclusion criteria (4 listed)
- Subjects who have other cancer history
- Pregnant females
- Subjects with active, known or suspected autoimmune disease.
- Known history of human immunodeficiency virus (HIV)
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 cell
Time frame: 1 years
Isolation and analysis of circulating tumor cells before and after immunotherapy
1 secondary outcome
tumor related rare cell
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
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 CTC and Tumor Related Rare Cell, run by MiCareo Taiwan Co., Ltd. at 1 site in Taiwan.
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 3 inclusion and 4 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 16 Aug 2018. 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 Taiwan. 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 Wang Shin-Hang (886-2796-5096 ext. 621, henrywang@micareo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating tumor cell (time frame: 1 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 16 Aug 2018.