Establishment of Preclinical Models from Patients with Gynecological Malignancies

Overview

About this study

Effective treatments for recurrent gynecological cancer are lacking, and there is a need for novel therapeutic options. One of the barriers to improving outcomes in this subgroup of patients is the paucity of tumor models that can mimic patient characteristics to study novel therapies. Patient-derived xenograft (PDX) models are considerate the most representative pre-clinical model of human cancer, recapitulating the key characteristics of the original patient tumor. Other preclincal models to test drug effcicacy includes ex vivo 3D culture and 2D culture systems. In this study, we make and test preclinical models of gynecological cancers (ovarian, fallopian tube, peritoneal, uterine, vulvar, cervix, and vaginal) of any histologic subtype using surplus tumor specimens obtained at the time of routine tumor biopsy procedure, or clinically-indicated surgery.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Females of age ≥ 16 years at pre-registration.
  • Previous diagnosis of gynecological malignancy (any histology, grade and stage) and current diagnosis of new or recurrent disease.
  • Patient will meet one of these two criteria for tissue.
  • Patient has disease amenable to biopsy and is agreeable to undergo a biopsy. 
    • NOTE:  Under unusual circumstances, submission of pleural fluid or ascites material may be acceptable if a biopsy is not possible. This will require approval by one of the study Principal Investigators.
  • Patient has disease amenable to be surgically resected and is agreeable to undergo the surgical procedure.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Women known to be pregnant are excluded.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Saravut Weroha, M.D., Ph.D.

Open for enrollment

Contact information:

Valentina Zanfagnin M.D.

(507) 538-5933

zanfagnin.valentina@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Saravut Weroha, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20387129

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