CancerNCT04280640
Relationship Between Circulating Tumor Cell Cultures' Treatment Response and Clinical Outcomes
An observational study of Cancer and Metastasis Lung, run by UNC Lineberger Comprehensive Cancer Center.
Trial summary
The purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (CTC) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Metastasis Lung, Metastasis to Liver
- What is being tested?
- Blood Draw
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Jun 2023
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients with liver and/or lung metastasis who will receive systemic treatment.
Who may be able to join
- Patients with a metastatic solid tumor malignancy with either liver and/or lung metastasis. Patients with newly diagnosed metastatic disease who have not had systemic therapy or are progressing on systemic therapy fitting one of the following cohorts:
- Patients had a tumor or liquid biopsy with molecular analysis (genomic analysis or other type of molecular characterization) resulting in a therapeutic target with planned targeted therapy by the patient's treating physician.
- Gastric cancer patients who have failed the first and second line chemotherapy.
- Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment.
- Scheduled to initiate systemic treatment for management of their disease. The systemic treatment will be either cytotoxic chemotherapy or targeted therapy but not checkpoint inhibitor immunotherapy.
- ≥18 years of age
- Written informed consent obtained and signed
- Able to have blood collection without excessive difficulty
Who cannot join
- Patient unwilling or unable to complete informed consent
- Currently pregnant or lactating women
- Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
About this study
Official title: LCCC 1938: Investigating the Relationship Between Circulating Tumor Cell Cultures Treatment Response and Clinical Outcomes
The purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (CTC) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease.
Read the detailed description
This study will isolate circulating tumor cells (CTCs) from blood samples taken from patients with liver and/or lung metastases who will receive systemic treatments. The CTCs will be cultured and given the same treatment as the patient received. The main goals of this project are 1) to assess CTC cultures' treatment response and compare the in vitro response to the clinical response, and 2) determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).
- Conditions
- Cancer, Metastasis Lung, Metastasis to Liver, Circulating Tumor Cell, Gastrointestinal Cancer, Bladder Cancer
- Being tested
- Blood Draw
- Medical subject headings
- Neoplasms, Neoplastic Cells, Circulating, Gastrointestinal Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawOther
A blood sample will be collected once, prior to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Cancer Pts Receiving Molecularly Targeted Therapy | Metastatic cancer patients (with liver and/or lung metastasis) who will receive molecularly targeted therapy based on genomic testing data Receives: Other: Blood Draw | |
| GI Cancer Pts | Gastrointestinal cancer patients (with liver and/or lung metastasis) who will receive 3rd line treatments or enrolled on a targeted therapy treatment trial Receives: Other: Blood Draw | |
| Bladder Cancer Pts | Bladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment Receives: Other: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between treatment response in CTCs and in vivo
To estimate the agreement between CTC cultures' response to treatment, dichotomized as either yes or no response, to the clinical response in patients to treatment, dichotomized as either progressive disease (PD) versus complete response (CR), partial response (PR), or stable disease (SD)
Measured: Initiation of trial to 24 months post-initiation
Secondary outcomes (1)
Sensitivity, specificity, and predictive values of CTC cultures' treatment response
To determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD)
Measured: Initiation of trial to 24 months post-initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study startJun 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: PI left UNC.
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.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Z Wang, MD, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280640
- Sponsor's protocol ID
- LCCC1938
- Status last verified
- Oct 2021
- First submitted
- 19 Feb 2020
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 1938: Investigating the Relationship Between Circulating Tumor Cell Cultures Treatment Response and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT04280640
- Acronym / sponsor ID
- LCCC1938
- Conditions
- Cancer, Metastasis Lung, Metastasis to Liver, Circulating Tumor Cell, Gastrointestinal Cancer, Bladder Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI left UNC.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 21 Feb 2020 (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 purpose of this prospective, non-randomized, single-center pilot exploratory study is to investigate whether established circulating tumor cell (CTC) cultures have a similar response to targeted therapy treatment as the in vivo (patients') disease.
Detailed description
This study will isolate circulating tumor cells (CTCs) from blood samples taken from patients with liver and/or lung metastases who will receive systemic treatments. The CTCs will be cultured and given the same treatment as the patient received. The main goals of this project are 1) to assess CTC cultures' treatment response and compare the in vitro response to the clinical response, and 2) determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of CTC cultures' response in predicting clinical response including complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metastatic Cancer Pts Receiving Molecularly Targeted Therapy | – | Other: Blood DrawMetastatic cancer patients (with liver and/or lung metastasis) who will receive molecularly targeted therapy based on genomic testing data |
| GI Cancer Pts | – | Other: Blood DrawGastrointestinal cancer patients (with liver and/or lung metastasis) who will receive 3rd line treatments or enrolled on a targeted therapy treatment trial |
| Bladder Cancer Pts | – | Other: Blood DrawBladder cancer patients (with liver and/or lung metastasis) who will receive systemic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients with liver and/or lung metastasis who will receive systemic treatment.
Key inclusion criteria (8 listed)
- Patients with a metastatic solid tumor malignancy with either liver and/or lung metastasis. Patients with newly diagnosed metastatic disease who have not had systemic therapy or are progressing on systemic therapy fitting one of the following cohorts:
- Scheduled to initiate systemic treatment for management of their disease. The systemic treatment will be either cytotoxic chemotherapy or targeted therapy but not checkpoint inhibitor immunotherapy.
- ≥18 years of age
- Written informed consent obtained and signed
- Able to have blood collection without excessive difficulty
Key exclusion criteria (3 listed)
- Patient unwilling or unable to complete informed consent
- Currently pregnant or lactating women
- Physical or psychological inability to complete sample collection for any reason including but not limited to: inability to tolerate any study procedures, any physical limitation that would undermine the safety of the subject in the study, or any psychiatric or neurological condition that inhibits full comprehension of study requirements and inability to complete informed consent, as determined by treating physician
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 DrawA blood sample will be collected once, prior to treatment. | Other | Bladder Cancer Pts, GI Cancer Pts, Metastatic Cancer Pts Receiving Molecularly Targeted Therapy |
Primary outcome
Correlation between treatment response in CTCs and in vivo
Time frame: Initiation of trial to 24 months post-initiation
To estimate the agreement between CTC cultures' response to treatment, dichotomized as either yes or no response, to the clinical response in patients to treatment, dichotomized as either progressive disease (PD) versus complete response (CR), partial response (PR), or stable disease (SD)
1 secondary outcome
Sensitivity, specificity, and predictive values of CTC cultures' treatment response
Time frame: Initiation of trial to 24 months post-initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
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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.
Andrew Z Wang, MD principal investigator
UNC Chapel Hill
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Metastasis Lung, run by UNC Lineberger Comprehensive Cancer Center.
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 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: withdrawn, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Correlation between treatment response in CTCs and in vivo (time frame: Initiation of trial to 24 months post-initiation). 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 18 Oct 2021.