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Anti-tumor chemotherapy
Assay-Directed Chemotherapy for Ovarian Cancer
Phase 3
Waitlist Available
Research Sponsored by Cordgenics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Negative pregnancy test for women of childbearing potential
Participant has disease of specific histologic epithelial cell types
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing whether a test that predicts how a person will respond to chemotherapy can help treat ovarian cancer.
Who is the study for?
This trial is for women over 18 with recurrent platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. They should have had ≤ 5 prior treatments and a good performance status. Participants must not be pregnant, using effective contraception if of childbearing potential, and able to provide tumor samples.Check my eligibility
What is being tested?
The study tests if ChemoID assay can predict the effectiveness of chemotherapy in treating certain types of ovarian cancer. Women will receive standard chemotherapy guided by the results of this assay to see if it improves treatment outcomes.See study design
What are the potential side effects?
Side effects are not specified but may include those typically associated with standard chemotherapy such as nausea, fatigue, hair loss, increased risk of infection, and possible discomfort from biopsy procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant.
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My cancer originates from certain types of lining cells.
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I've had 5 or fewer treatments for my cancer, including one with platinum.
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I am a woman and I am 18 years old or older.
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I have a type of ovarian, peritoneal, or fallopian tube cancer that has come back and does not respond to platinum-based chemotherapy.
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I can provide a fresh sample for ChemoID testing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate
Secondary outcome measures
CA125 levels
Duration of Response
Health-Related Quality of Life (HRQOL)
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ChemoID-guided treatmentExperimental Treatment1 Intervention
Participants will be treated with ChemoID-guided standard-of-care chemotherapy drugs from the provided list.
ChemoID-guided treatment will be chosen from the following standard-of-care chemotherapy drugs or combinations:
Liposomal Doxorubicin;
Docetaxel;
Paclitaxel;
Carboplatin;
Cisplatin;
Gemcitabine;
Topotecan;
Carboplatin, Gemcitabine;
Cisplatin, Gemcitabine;
Carboplatin, Liposomal Doxorubicin;
Carboplatin, Paclitaxel;
Carboplatin, Docetaxel.
The treating physician will receive the ChemoID assay results from the ChemoID lab.
Group II: Physician Choice TreatmentActive Control2 Interventions
Participants will be treated with control chemotherapy treatment (standard-of-care chemotherapy chosen by the physician from the provided list).
Control chemotherapy treatment will be chosen from any of the following standard-of-care chemotherapy drugs or combinations:
Liposomal Doxorubicin;
Docetaxel;
Paclitaxel;
Carboplatin;
Cisplatin;
Gemcitabine;
Topotecan;
Carboplatin, Gemcitabine;
Cisplatin, Gemcitabine;
Carboplatin, Liposomal Doxorubicin;
Carboplatin, Paclitaxel;
Carboplatin, Docetaxel. The treating physician will NOT receive the ChemoID assay results from the ChemoID lab.
Find a Location
Who is running the clinical trial?
Cordgenics, LLCLead Sponsor
2 Previous Clinical Trials
378 Total Patients Enrolled
Thomas Herzog, MDStudy ChairUniversity of Cincinnati
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant.I have a specific type of ovarian cancer.My cancer originates from certain types of lining cells.I am planned to be treated with Avastin.The doctor thinks you may have less than 6 months to live.I am not using any herbal or alternative medicines.I agree to provide a tissue sample from my cancer or undergo a procedure to collect fluid.I've had 5 or fewer treatments for my cancer, including one with platinum.You have a disease that can only be measured by CA-125 and not by other standard methods.I need chemotherapy, and my doctor has chosen a specific treatment plan for me.My cancer can be measured or tracked using specific tests.My cancer is a type of borderline, mucinous, or low-grade serous carcinoma.I am a woman and I am 18 years old or older.I can take care of myself and perform daily activities.I have a type of ovarian, peritoneal, or fallopian tube cancer that has come back and does not respond to platinum-based chemotherapy.My only cancer site is in the fluid-filled areas of my body.I have heart problems that cause symptoms.I can provide a fresh sample for ChemoID testing.
Research Study Groups:
This trial has the following groups:- Group 1: ChemoID-guided treatment
- Group 2: Physician Choice Treatment
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available openings for participants in this trial?
"Yes, this study is still recruiting patients according to the information available on clinicaltrials.gov. The listing for this trial was first posted on 26 July 2019 and was last updated 16 October 2021."
Answered by AI
Are there different hospitals or research centers participating in this trial across America?
"In addition to LSU Health Sciences Center in New Orleans, Louisiana and West Penn Hospital, Allegheny Health Network in Pittsburgh, Pennsylvania; this trial is also enrolling patients at Charleston Area Medical Center (CAMC) in Charleston, West virginia. There are a total of 10 locations where recruitment is taking place."
Answered by AI
Does the ChemoID Assay go through the FDA's rigorous approval process?
"ChemoID Assay is considered to be safe, as it has reached Phase 3 in clinical trials. This suggests that not only is there some evidence of efficacy, but also that multiple rounds of testing have confirm its safety."
Answered by AI
How many people have signed up to participate in this clinical trial?
"To enroll in this study, 220 eligible patients are required. These participants can come from various recruitment sites such as LSU Health Sciences Center located in New Orleans or West Penn Hospital part of the Allegheny Health Network situated in Pittsburgh."
Answered by AI
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