Brief Title
A Pilot Study Investigating the Effect of Chemotherapy on the Tumoral Immunoprofile of Gynecologic Cancers
Official Title
A Pilot Study Investigating the Effect of Chemotherapy on the Tumoral Immunoprofile of Gynecologic Cancers
Brief Summary
The investigators propose to collect biologic samples (i.e. tumor tissue, ascites, and/or
blood), from patients undergoing standard of care therapy for a gynecologic malignancy. To
detect changes in the immune response following chemotherapy, collection of biologic samples
will occur at baseline and at the time of surgery following chemotherapy.
Detailed Description
This is a single-institution, non-interventional prospective observational study allowing for
specimen and data collection. All participants will receive standard of care surgery and
chemotherapy, determined by the gynecologic oncologist and per institutional protocols.
Patients with a presumed diagnosis of an eligible gynecologic malignancy (epithelial ovarian,
fallopian tube, primary peritoneal, or uterine endometrial cancer) who are being considered
for neoadjuvant chemotherapy prior to confirmatory biopsy will be given the option to enroll
on this study.
Patients will undergo standard biopsy or endometrial curettage to confirm diagnosis.
Additional tumor tissue for research purposes will be collected at the time of biopsy (if
safely available). Patients who are undergoing diagnostic or therapeutic paracentesis will
have the option to consent to allow excess ascites to be evaluated in this research protocol.
Additionally, a research blood sample will be collected on the same day as the
biopsy/curettage.
After confirmation of diagnosis, chemotherapy administration will proceed per standard
institutional protocol and surgical planning will be performed by the treating gynecologic
oncologist. Excess tumor tissue and ascites from the cytoreductive surgery will be collected
for immune profiling. An additional vial of blood for research will be collected within 3
days prior to surgery. Post-surgical treatment and chemotherapy will proceed per standard
procedures. After completion of post-surgical adjuvant therapy, an additional vial of blood
for research will be collected (at next scheduled clinic visit).
Study Type
Observational
Primary Outcome
Change in number and type of tumor infiltrating lymphocytes
Condition
Ovarian Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
47
Start Date
June 2016
Completion Date
December 2021
Primary Completion Date
December 2021
Eligibility Criteria
Inclusion Criteria:
1. Presumed diagnosis of tumor of müllerian origin, specifically epithelial ovarian,
fallopian tube, primary peritoneal, or uterine endometrial cancer. After biopsy
portion of study, only patients with histologically or cytologically confirmed
diagnosis of eligible malignancies will continue.
2. Be considered a candidate for neoadjuvant chemotherapy per institutional standards.
3. Be willing and able to provide written informed consent for the trial.
4. Be ≥ 18 years of age on day of signing informed consent.
5. Be willing to provide tissue from a newly obtained core or excisional biopsy of a
tumor lesion. Subjects for whom newly-obtained samples cannot be provided (e.g.
inaccessible or subject safety concern) may submit an archived specimen upon agreement
of the investigator.
6. Have a performance status of 0-2 on the ECOG Performance Scale.
7. Female subjects of childbearing potential should have a negative urine pregnancy test
within 48 hours prior initial biopsy or administration of chemotherapy whichever comes
first.
Exclusion Criteria:
1. Is currently participating and receiving a study therapy or has participated in a
study of an investigational agent and received study therapy or used an
investigational device for this diagnosis.
2. Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the
skin that has undergone potentially curative therapy, or in situ cervical cancer.
3. Has a history or current evidence of any condition (i.e. infection), therapy, or
laboratory abnormality that might confound the results of the study, interfere with
the subject's participation for the full duration of the trial, or is not in the best
interest of the subject to participate, in the opinion of the treating investigator.
4. Has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial.
5. Is pregnant or breastfeeding.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Angeles A Secord, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02824328
Organization ID
Pro00066330
Secondary IDs
5K12HD043446-14
Responsible Party
Sponsor
Study Sponsor
Duke University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Sponsor
Angeles A Secord, MD, Principal Investigator, Duke Cancer Institute
Verification Date
May 2020