A Pilot Study Investigating the Effect of Chemotherapy on the Tumoral Immunoprofile of Gynecologic Cancers

NCT02824328 | Completed

• 2 other identifiers: Pro000663305K12HD043446-14
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer; Uterine Endometrial Cancer

Outcome Measures

Primary Outcomes (4)

• Change in number and type of tumor infiltrating lymphocytes

  To assess changes in the immune response through the characterization of tumor infiltrating lymphocytes (TILs) after administration of chemotherapy. Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.

  baseline, post treatment (approximately 6 months)

• Change in expression level of Inflammatory mediators

  To assess changes in immune response through the characterization of inflammatory mediators after administration of chemotherapy. Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.

  baseline, post treatment (approximately 6 months)

• Change in tumor expression level of PD-L1

  To assess changes in the immune response through the characterization of tumor expression of PD-L1 after administration of chemotherapy. Identify immune signatures/biomarkers that predict treatment outcomes. Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.

  baseline, post treatment (approximately 6 months)

• Changes in HLA-type

  To assess changes in HLA-type after administration of chemotherapy. Identify immune signatures/biomarkers that predict treatment outcomes. Biomarker testing is for the purpose of biological research and is not intended to test or develop an in-vitro diagnostic test.

  baseline, post treatment (approximately 6 months)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.
• Be considered a candidate for neoadjuvant chemotherapy per institutional standards.
• Be willing and able to provide written informed consent for the trial.
• Be ≥ 18 years of age on day of signing informed consent.
• 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.
• Have a performance status of 0-2 on the ECOG Performance Scale.
• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding.

Sponsors & Collaborators

• Duke University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Blood (30ml) on the day of biopsy 2. Additional tissue at time of clinical biopsy (if it is safe for additional tissue to be collected during this time beyond what is clinically indicated, an effort will be made to do so. All biopsy tissue collected will be sent to pathology, including any additional tissue. Tissue remaining after pathology has performed their clinical care requirements will be collected) OR Collection of excess tissue at time of clinical biopsy (if it is unsafe for additional tissue to be collected, only tissue in excess of what is what pathology uses will be collected) 3. Excess ascites at time of paracentesis (if performed for diagnostic/therapeutic purposes) 4. Additional blood (30ml) within 3 days of surgery 5. Excess tumor tissue and ascites at the time of cytoreductive surgery 6. Blood (30ml) at the next scheduled visit after completion of post-surgical adjuvant therapy.

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Uterine Neoplasms; Uterine Diseases

Study Officials

• Angeles A Secord, MD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: June 1, 2016
• Primary Completion: July 25, 2019
• Study Completion: January 10, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-01

Locations

US (1)