NCT05869994

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

January 27, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

January 20, 2023

Last Update Submit

July 2, 2024

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarcoma Oncology Research Center

Santa Monica, California, 90403, United States

Location

Related Publications (1)

  • 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.

    PMID: 26513416BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tumor specimens from patients with sarcoma who are scheduled for elective surgery.

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Erlinda M Gordon, MD

    Sarcoma Oncology Research Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2023

First Posted

May 23, 2023

Study Start

January 27, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 5, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)