NCT03230240

Brief Summary

To ascertain immunologic profile of peritoneal cavity and its relationship to immediate postsurgical outcome (morbidity or the treatment) and long-term outcome (time to recurrence and survival).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2016

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

July 26, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

4.8 years

First QC Date

February 8, 2016

Last Update Submit

September 20, 2020

Conditions

Carcinomatosis

Outcome Measures

Primary Outcomes (1)

  • In vitro growth of Staph Aureus and Escherichia coli measured in millimeters of colony forming unit on Agar plate

    1 year after operation

Study Arms (1)

HIPEC

Patients with carcinomatosis or other peritoneal surface malignancy

Drug: HIPEC

Interventions

HIPECDRUG

heated intraIP chemotherapy

Also known as: Hyperthermic intraperitoneal chemotherapy
HIPEC

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with peritoneal carcinomatosis undergoing intraperitoneal chemotherapy.

You may qualify if:

  • HIPEC pt

You may not qualify if:

  • absent consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MercyOne Des Moines Medical Center

Des Moines, Iowa, 50314, United States

Location

Related Publications (1)

  • Franko J, Brahmbhatt R, Tee M, Raman S, Ferrel B, Gorvet M, Andres M. Cellular Immunoprofile of Peritoneal Environment During a HIPEC Procedure. Ann Surg Oncol. 2020 Dec;27(13):5005-5013. doi: 10.1245/s10434-020-08870-3. Epub 2020 Jul 21.

    PMID: 32696309RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

ascites

MeSH Terms

Conditions

Carcinoma

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Chemotherapy, AdjuvantCombined Modality TherapyTherapeuticsDrug TherapyHyperthermia, Induced

Study Officials

  • Jan Franko, MD, PhD

    MercyOne Des Moines Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Surgical Oncologist

Study Record Dates

First Submitted

February 8, 2016

First Posted

July 26, 2017

Study Start

January 1, 2016

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

September 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)