Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Study of Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer (Ovarian Spore)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00801320

Enrollment

100

Registered

2008-12-03

Start date

2008-09-30

Completion date

2020-08-31

Last updated

2020-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cancer

Keywords

tumor harvest, tumor collection, tumor storage

Brief summary

The purpose of this research study is to collect tumor samples at the time of surgery and store them for possible use as part of an experimental vaccine study for the participants cancer in the future.

Detailed description

* Even if tumor sample is collected, the participant is under no obligation to participate in the vaccine study. * Participants will have their regularly planned surgery as described by their surgeon. During the surgery, tumor samples will be collected. We will only collect tumor that is not needed and could otherwise be thrown away. * The tumor samples will be frozen and placed in storage for up to two years.

Interventions

PROCEDURETumor collection

Tumor collected at the time of planned surgery

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical suspicion of advanced ovarian, fallopian tube or primary peritoneal cancer as determined by a gynecologic oncologist * Patients are planning to undergo primary or secondary debulking surgery as part of standard of care for their disease * Estimated life expectancy of 6 months or greater * 18 years of age or older

Exclusion criteria

* More than one prior chemotherapy regimen * Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, unstable ischemic coronary disease or congestive heart failure * Known HIV infection * Active second malignancy, aside from basal cell or squamous cell carcinoma of the skin * Significant autoimmune disease, including psoriasis * History of clinically significant venous thromboembolism

Design outcomes

Primary

Measure	Time frame
To collect patient tumor samples that could possibly be used in a subsequent clinical vaccine trial (DF/HCC protocol 07-380).	2 years
To gain experience in appropriate clinical processing of tumor samples and determining cell yield.	2 years

Secondary

Measure	Time frame
Based on feasibility of collection of blood samples of subjects, quantification of T cell subsets, regulatory T cells, activated memory effector cells, and DC phenotype at pre-surgery and post-surgery time points.	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026