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

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ClinicalTrials.gov Identifier: NCT02824328
Recruitment Status : Active, not recruiting
First Posted : July 6, 2016
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Ovarian Cancer Fallopian Tube Cancer Peritoneal Cancer Uterine Endometrial Cancer

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).

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Pilot Study Investigating the Effect of Chemotherapy on the Tumoral Immunoprofile of Gynecologic Cancers
Study Start Date : June 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021





Primary Outcome Measures :
  1. Change in number and type of tumor infiltrating lymphocytes [ Time Frame: baseline, post treatment (approximately 6 months) ]
    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.

  2. Change in expression level of Inflammatory mediators [ Time Frame: baseline, post treatment (approximately 6 months) ]
    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.

  3. Change in tumor expression level of PD-L1 [ Time Frame: baseline, post treatment (approximately 6 months) ]
    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.

  4. Changes in HLA-type [ Time Frame: baseline, post treatment (approximately 6 months) ]
    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.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824328


Locations
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United States, North Carolina
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Angeles A Secord, MD Duke Cancer Institute
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02824328    
Other Study ID Numbers: Pro00066330
5K12HD043446-14 ( U.S. NIH Grant/Contract )
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Endometrial Neoplasms
Fallopian Tube Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases
Fallopian Tube Diseases