CLINICAL TRIAL

Tumour tissue collection for Gynecologic Cancers

Stage III
Recruiting · 18+ · Female · Toronto, Canada

This study is evaluating whether a sample of biological samples can be collected from gynecological cancer patients for biomarker research.

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About the trial for Gynecologic Cancers

Treatment Groups

This trial involves 2 different treatments. Tumour Tissue Collection is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ascites Collection
PROCEDURE
Blood sample collection
PROCEDURE
Fluid Collection
PROCEDURE
Tumour tissue collection
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood sample collection
2014
Completed Phase 4
~13020

Eligibility

This trial is for female patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Histological diagnosis of stage III or IV high grade serous ovarian, tubal or primary peritoneal cancer.
Must be 18 years of age or older.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
Have a life expectancy greater than or equal to 6 months.
Able to provide adequate informed consent.
Willing to undergo blood or fluid collection and tumour biopsy
Patients enrolled at the time of surgery must agree to have part of their tumour used for the purpose of the study.
Archival tissue must be available for patients that are enrolled at the time of progression.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 10 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 10 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Tumour tissue collection will improve 4 primary outcomes in patients with Gynecologic Cancers. Measurement will happen over the course of 10 years.

Genomic and immune signatures in terms of overall survival
10 YEARS
Short term (1-2 years) versus long term (5-10 years) survival
10 YEARS
Genomic and immune signatures in terms of response to treatments
10 YEARS
10 YEARS
Genomic and immune signatures in terms of progression free survival
10 YEARS
Short term (1-2 years) versus long term (5-10 years) survival
10 YEARS
Genomic and immune signatures in terms of resistance to treatments
10 YEARS
10 YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can gynecologic cancers be cured?

Despite a cure for cervix, non-surgical treatment of endometrial cancer does not appear to change the risk of death from endometrial cancer, while there is no evidence that surgical treatment decreases the risk of death from uterine cancers.

Anonymous Patient Answer

What causes gynecologic cancers?

Infectious diseases and genetic mutations are likely candidates, and there is some evidence that UV radiation and exposure to certain drugs, chemicals, or environmental toxins may also increase risk.

Anonymous Patient Answer

What are the signs of gynecologic cancers?

Women with some signs of gynecologic cancers may develop symptoms at various stages in their lifetimes, which may include changes in menstrual cycles, abnormal vaginal bleeding, discharge from the vagina, or an abnormal vaginal exam. Although not all symptoms have a specific etiology, the following signs may be associated with women’s cancer screenings: abnormal vaginal bleeding with spotting in the first trimester, an abnormal vaginal exam in the first trimester, pelvic pain and abdominal pains in the third trimester, pelvic pain in the third trimester, lower abdominal pain or bloating after having a child, discharge or spotting following a hysterectomy, vaginal discharge or spotting after hysterectomy.

Anonymous Patient Answer

How many people get gynecologic cancers a year in the United States?

The American Cancer Society estimates that there will be approximately 250,000 diagnoses of breast and [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer) during 2019. The projected 5-year survival rates for invasive breast cancer are 60% and 56% for advanced breast cancer, respectively; whereas the projected 5-year survival rates for ovarian cancer are 45% and 32% for advanced ovarian cancer following primary treatment. Survival from ovarian cancer is associated with age, while survival from breast cancer is associated with ER+. The 5-year survival rate for pancreatic cancer remains elusive. Around 22,000 cases of pancreatic cancer are projected to be diagnosed in U.S. during 2019, with a 12% 5-year survival rate.

Anonymous Patient Answer

What are common treatments for gynecologic cancers?

Common treatments vary widely depending on the type and extent of each individual patient's cancer. Most common treatments for gynecologic cancers revolve around platinum-based chemotherapy, and surgery may be considered to shrink or eliminate the spread of cancer. A variety of treatment options are available in most cases.

Anonymous Patient Answer

What is gynecologic cancers?

Gynecologic cancers are highly variable in causation, presentation, and treatment based on the location and stage of the cancer in the reproductive organs and/or the surrounding reproductive structures. Gynecologic cancers can occur in almost every organ in the reproductive tract. In addition to its use as an umbrella term, the common term “gynecologic cancers” should be used instead of “cancer of the reproductive tract” or “genital cancers” to better describe these conditions and their variations in presentation and treatment. © 2016 Wiley Periodicals, Inc.

Anonymous Patient Answer

Is tumour tissue collection typically used in combination with any other treatments?

Over the last ten years, tumour harvesting has become more widespread in the management of patients with gynecological malignancies. The most common combination is lymphadenectomy with other modalities (chemo- and/or radiotherapy). The majority of the patients had clinical stage IA-B1, or good prognostic features. Lymphadenectomy was the most important clinical practice. Findings from a recent study demonstrated that tumour collections in pelvic node-free patients are not necessary to treat with local modalities. The combination with any other treatments was uncommon.

Anonymous Patient Answer

Have there been any new discoveries for treating gynecologic cancers?

The current treatment paradigm has not significantly changed over the last decade. There is a lack of clinical trial evidence and high rates of patient dropouts from clinical trials. Clinical trial results are often only used by institutions to implement their specific protocols; there is no indication of which patients benefit most from which protocol. A number of gynecological oncology trials are urgently needed to treat gynecologic cancers and improve patient outcomes.

Anonymous Patient Answer

What is the average age someone gets gynecologic cancers?

By using Power, you can find the average age people go to get breast, ovarian, and uterine cancers. For gynecologic cancers, this age is approximately 51 years. By using [HealthGrades(https://www.healthgrades.com/)], you can compare age of diagnosis for breast, ovarian, and uterine cancers. For breast cancer, this age is approximately 53 years; [Ovarian cancer age is approximately 67 years, and uterine cancer age is approximately 66 years]. For gynecologic cancers, this age may vary significantly from year to year.

Anonymous Patient Answer

What is tumour tissue collection?

The majority of respondents reported a collection programme for all patients, but only some respondents collected tumour tissues from those who died. A significant proportion of patients reported that their tumour tissues should not be collected. Given that the potential of cancer germline tumour mutations to be tested is increasing, further study is required on how patients should be informed and educated about tumour tissue collections.

Anonymous Patient Answer

Does tumour tissue collection improve quality of life for those with gynecologic cancers?

Results from a recent paper demonstrated that tumour tissue collection in gynecologic cancer patients seems to have an impact on the patient's quality of life.

Anonymous Patient Answer

What are the common side effects of tumour tissue collection?

After tumour tissue collection the most common side effects were: fatigue, nausea, pain and itching of skin or mucosa. Most side effects were mild and were not harmful, but some were more severe especially nausea and itchiness. For patient comfort the most important issue was whether or not the patient has to take drugs.

Anonymous Patient Answer
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