SarcomaNCT05869994
Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures
An observational study of Sarcoma, run by Sarcoma Oncology Research Center, LLC at 1 site in United States.
Trial summary
The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2023to 1 Jul 2024
- 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
- Adult, Older adult
Study population: Male and female subjects > 18 years of age, of any ethnicity, with advanced soft tissue sarcoma will be recruited via patient referrals from the medical community, patient request for participation through internet research, patients being treated at the Sarcoma Oncology Research.
Who may be able to join
- Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:
- Male or Female ≥ 18 years of age
- Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma
- Patients who are already scheduled for surgery
- Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee
- Willingness to comply with all study procedures and availability for the duration of the study.
Who cannot join
- Patients who do not meet inclusion criteria.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Sarcoma Oncology Research Center
Santa Monica, California, 90403
About this study
The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.
Read the detailed description
The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.
Study Design:
One hundred mL of blood will be collected in an EDTA container and transported to the laboratory for in vitro isolation and expansion of NK cell cultures.
Two or three weeks later, 25 cu mm of the patient's own tumor will be collected in PBS and transported to the laboratory for co-culture with autologous expanded and enhanced NK cells.
Inclusion Criteria:
Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:
- Male or Female ≥ 18 years of age
- Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma
- Patients who are already scheduled for surgery
- Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee
- Willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria: Patients who do not meet the inclusion criteria.
Methodology:
Male and female subjects > 18 years of age, of any ethnicity, with advanced soft tissue sarcoma will be recruited via patient referrals from the medical community, patient request for participation through internet research, patients being treated at the Sarcoma Oncology Research.
Study Duration:
The study is expected to take 24-30 months
Statistical Analysis Plan For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate. Assuming the required statistical power of 0.9 with a significance level of 0.05 and effect size of 0.4, an equal sample size of at least 19 is suggested for each group: 1) Untreated, 2) CH-SCP, 3) Nk cells and 4) CH-SCP-NK-based hydrogel. Differences in mean tumor growth and survival rate between the control and experimental groups at each time point will be tested with independent ANOVA followed by Tukey's HSD test as a post-hoc analysis where appropriate.
Baseline Descriptive Statistics Demographics, age, ethnicity, subtypes of sarcoma, number of patients, patients with locally advanced or metastatic will be described using descriptive statistics.
- Conditions
- Sarcoma
- Medical subject headings
- Sarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor activity
Inhibition of autologous cancer cell growth in vitro by autologous natural killer cells using an automated cell counter. For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start27 Jan 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024 (estimated)
Why it stopped: Inactive study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarcoma Oncology Research Center, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erlinda M Gordon, MD, Principal investigator, Sarcoma Oncology Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05869994
- Sponsor's protocol ID
- SOC-2205
- Status last verified
- Jul 2024
- First submitted
- 20 Jan 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monette A, Ceccaldi C, Assaad E, Lerouge S, Lapointe R. Chitosan thermogels for local expansion and delivery of tumor-specific T lymphocytes towards enhanced cancer immunotherapies. Biomaterials. 2016 Jan;75:237-249. doi: 10.1016/j.biomaterials.2015.10.021. Epub 2015 Oct 9.
PubMed 26513416
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autologous Natural Killer Cell Activity in Primary Cancer Cell Cultures
- ClinicalTrials.gov ID
- NCT05869994
- Acronym / sponsor ID
- SOC-2205
- Conditions
- Sarcoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Inactive study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sarcoma Oncology Research Center, LLCUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 23 May 2023 (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 objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.
Detailed description
The objectives of the study is to evaluate the anti-tumor activity of autologous natural killer cells in cultures of cancer cells obtained from patient's own tumor.
Study Design:
One hundred mL of blood will be collected in an EDTA container and transported to the laboratory for in vitro isolation and expansion of NK cell cultures.
Two or three weeks later, 25 cu mm of the patient's own tumor will be collected in PBS and transported to the laboratory for co-culture with autologous expanded and enhanced NK cells.
Inclusion Criteria:
Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:
- Male or Female ≥ 18 years of age
- Pathologically confirmed diagnosis of locally advanced unresectable or metastatic soft tissue sarcoma
- Patients who are already scheduled for surgery
- Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the investigator's IRB/Ethics Committee
- Willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria: Patients who do not meet the inclusion criteria.
Methodology:
Male and female subjects > 18 years of age, of any ethnicity, with advanced soft tissue sarcoma will be recruited via patient referrals from the medical community, patient request for participation through internet research, patients being treated at the Sarcoma Oncology Research.
Study Duration:
The study is expected to take 24-30 months
Statistical Analysis Plan For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate. Assuming the required statistical power of 0.9 with a significance level of 0.05 and effect size of 0.4, an equal sample size of at least 19 is suggested for each group: 1) Untreated, 2) CH-SCP, 3) Nk cells and 4) CH-SCP-NK-based hydrogel. Differences in mean tumor growth and survival rate between the control and experimental groups at each time point will be tested with independent ANOVA followed by Tukey's HSD test as a post-hoc analysis where appropriate.
Baseline Descriptive Statistics Demographics, age, ethnicity, subtypes of sarcoma, number of patients, patients with locally advanced or metastatic will be described using descriptive statistics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and female subjects > 18 years of age, of any ethnicity, with advanced soft tissue sarcoma will be recruited via patient referrals from the medical community, patient request for participation through internet research, patients being treated at the Sarcoma Oncology Research.
Key inclusion criteria (6 listed)
- Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study, as follows:
Key exclusion criteria (2 listed)
- Patients who do not meet inclusion criteria.
- -
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
Antitumor activity
Time frame: 1 month
Inhibition of autologous cancer cell growth in vitro by autologous natural killer cells using an automated cell counter. For the in vitro studies, multiple group comparisons at a single time point will be made via the independent analysis of variance (ANOVA) test, followed by Tukey's HSD test as a post-hoc test where appropriate.
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 5 Jul 2024.
- Background: PubMed 26513416Monette A, Ceccaldi C, Assaad E, Lerouge S, Lapointe R. Chitosan thermogels for local expansion and delivery of tumor-specific T lymphocytes towards enhanced cancer immunotherapies. Biomaterials. 2016 Jan;75:237-249. doi: 10.1016/j.biomaterials.2015.10.021. Epub 2015 Oct 9.
- 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.
Erlinda M Gordon, MD principal investigator
Sarcoma Oncology Research Center
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 Sarcoma, run by Sarcoma Oncology Research Center, LLC 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 6 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: withdrawn, as of the sponsor's last update on 5 Jul 2024. 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 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?
Antitumor activity (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05869994, which also lists 1 linked publication.
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 5 Jul 2024.