Clinical trial NCT03420118: Study of Biomarkers in Gynecological Cancers
Official title: Molecular and Immunological Characterization of Gynecological Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In recent years, there has been a significant improvement in understanding the biology of cancer and this information has been used to improve cancer care and patient outcome.

Research has shown that changes in some genes and/or proteins may be important indicators for certain cancers and response to treatments. Genes are molecules made up of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA). DNA contain instructions for the development and functioning of the cells in the body and are passed down from parent to child. RNA is involved with producing proteins in the body. Further research is needed to better understand the changes found in cancer cells and how to target them to stop or reduce cancer growth.

A drug that may be able to block certain specific cancer cell changes is called "targeted therapy". Different people with the same type of cancer receiving the same drug could have different responses to it. For example, one person may experience a reduction of their tumor while another person's cancer may worsen. The reason for this is still not well understood and could lie in gene changes.

Understanding these changes may allow researchers to predict how treatments may work in guiding decisions around choice of drugs.

The purpose of the study is to learn more about gene changes or protein expression (levels) of tumors to better understand the behavior of gynecological diseases and, if possible, better address participants' cancer care now or in the future.


Eligibility criteria: Pre-Screening Eligibility:

Inclusion Criteria:

* Patients with probable diagnoses of gynecological malignancy (ovarian, tubal, primary peritoneal, uterine, cervical, vulvar and rare gynecological cancers) and confirmed to be undergoing upfront debulking surgery/radiation
* Patient must be ≥16 years of age at the time of consent.
* Ability to understand and provide written informed consent.
* ECOG Performance Status ≤ 2.
* Patient must consent to provide tissue sample from surgery and blood samples
* Life expectancy ≥3 months.

Exclusion Criteria:

* Patients must be treatment naïve (no previous treatment of Neoadjuvant chemotherapy nor radiation for newly diagnosed disease)

Eligibility for Patients with Gynecological Diagnosis

Inclusion Criteria:

* Patients with histological confirmation of gynecological malignancy (except ovarian cancer with high grade serous histology, tubal, primary peritoneal, uterine, cervical, vulvar and vaginal cancer and rare gynecological cancers).
* Patient must be ≥16 years of age at the time of consent.
* Ability to understand and provide written informed consent.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
* Patient must consent to providing archival tissue and/or to undergo tumour biopsy and/or to provide blood or fluid collection samples. Patients will also be asked to provide a blood sample for germline mutation analysis.
* Life expectancy ≥3 months.
* No limits of previous lines of treatment.

Exclusion Criteria:

* Any contraindication to tumour biopsy or blood collection
* Patient with diagnosis of High grade serous Ovarian Cancer are excluded

Primary outcomes:
measure: Genomic and immune signatures in terms of progression free survival
timeFrame: 5 years
measure: Genomic and immune signatures in terms of overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Princess Margaret Cancer Centre
name: Amit Oza, M.D.
role: PRINCIPAL_INVESTIGATOR
References: