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Recruiting

NCT Number: NCT05844865

Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

This is a pilot study gathering and using samples and data from patients with gastrointestinal peritoneal carcinomatosis. Participants will be asked for permission to provide blood and ascites/peritoneal wash fluid, tumor samples during their planned surgical procedure.

Recruiting

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Key information

Conditions

Peritoneal Carcinomatosis Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Peritoneal Carcinomatosis Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, 92868, United States

Location status: Recruiting

Location contact

Maheswari Senthil, MD FACS

CONTACT

[email protected]

877-827-8839

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients must have a GI tumor
  • Must have planned standard of care surgical procedure
  • Age ≥ 18 years.
  • Ability to understand and the willingness to sign a written informed consent

Exclusion criteria

  • Pattens who are unable to comply with the study protocol

Treatment and study plan

Biospecimen Collection (Blood, Ascites/Peritoneal Wash Fluid and/or Tumor Samples)

Other

Subjects with a known diagnosis of GI primary tumor with or without PC, with a planned standard of care surgery.

Primary outcomes

  1. Establishment of angioarchitechture of peritoneal lesions through Optical Coherence Tomography Angiography (OCTA)

    Time frame: Up to 4 years

    Establishment and evaluation of angioarchitecture of peritoneal lesions through OCTA imaging obtained during surgery.

  2. Development of individual patient-derived peritoneal carcinomatosis (pdPC) vascularized micro-tumor (VMT)

    Time frame: Up to 4 years

    Successful establishment of multicellular pdPC VMT models from metastatic and/or primary tumor tissue with increasing tumor volume over a 14 day period.

Secondary outcomes

  1. Compare response of therapeutic regimens in a pdPC VMT to the observed clinical response (by RECIST criteria or diagnostic laparoscopy)

    Time frame: Up to 4 years

    Response to therapy in a pdPC VMT will be correlated with the clinical response observed in patients treated with similar regimens using either RECIST criteria if measurable disease is available or by diagnostic laparoscopy performed as part of standard of care to assess treatment response

  2. Progression-Free Survival (PFS) at 6 months

    Time frame: 6 months

    Survival analysis will utilized to study association between in vitro model and patient clinical response. Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 months will be made.

  3. Overall Survival (OS)

    Time frame: Up to 4 years

    Survival analysis will utilized to study association between in vitro model and patient clinical response. The duration of time from start of treatment to time of progression or death, whichever occurs first.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

[email protected]

1-877-827-7883

University of California Irvine Medical

CONTACT

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 6, 2023
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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