Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Vaginal Neoplasms

Vulvar Neoplasms

Uterine Neoplasms

Endometrial Neoplasms

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Uterine Cervical Diseases

Uterine Diseases

Fallopian Tube Diseases

Vulvar Diseases

Vaginal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Vaginal Cancer

Fallopian Tube Cancer

Vulvar Cancer

Dermatologic Agents

All Drugs and Chemicals

Coal Tar

This study will collect patient demographic, oncology history, and physician reported outcome information following the initial round of chemotherapy received after a commercial ChemoFx® Final Report for the generation of hypotheses of potential patient cohorts for further sub-studies.

The traditional treatment course for new cases of many cancers is cytoreductive surgery followed by chemotherapy. Unfortunately, despite high initial response rates to treatment, the majority of patients recur. The use of ineffective chemotherapy can result in unnecessary toxicity and costs, delay of more effective treatment, and the potential for the development of cross-resistance to additional drugs. The ability to individualize therapy by providing the treating physician with ex vivo response information on a panel of drugs should aid in the selection of effective therapy for individual patients, thus resulting in improved outcomes.

ChemoFx® is a drug response marker that quantifies an individual cancer patient's probable tumor response to various chemotherapeutic and biologic agents-providing both sensitivity and resistance information. In a retrospective study, it was demonstrated that patients treated with a regimen that the ChemoFx® test said the patients' cells would be sensitive to, corresponded to a 3 times longer progression free interval.

In the PT-206 ChemoFx PRO® study, patients will be followed through treatment, until the patient progresses or a significant change in chemotherapy occurs. This data will be collected and analyzed to identify potential patient cohorts for the development of hypotheses for future sub-study analysis. Also, tumor pathology slides and excess tumor cells (if available) will be used to characterize common polymorphisms in drug metabolizing enzymes as well as other molecular markers potentially associated with tumor response.

The PT-206 ChemoFx PRO® Study seeks to enroll an estimated 3,000 patients from 150 academic and community-based physicians in the U.S. The patients will be treated with drugs and/or drug combinations based on the medical judgment of the treating physician. This study is not randomized.

Leftover tumor cells from the test and pathology slides will be collected and stored to look for potential genetic variations related to drug pathway genes to identify patterns associated with clinical outcome.

ChemoFx® PRO - A Post-Market Data Collection Study

ChemoFx® PRO - A Post-Market Data Collection Study Utilizing Physician Reported Outcomes

Precision Therapeutics

ChemoFx

Holly Gallion, MD

The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.

This is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. Data from approximately 70 cases will be collected from approximately 10 study sites and correlated to the ChemoFx drug response marker results. The outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. Objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy. Overall Survival will be measured from the start of chemotherapy to the actual date of death.

Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients

Retrospective Case Study to Determine the Correlation of Patient Outcome to the ChemoFx Assay in Cases With Late Stage Endometrial Cancer

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Test of an algorithm to predict pathologic response in patients treated with neoadjuvant chemotherapy for breast cancer.

ChemoFX Assay

Darrell Lis, RN, MSN

The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient.

The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient. The anticipated biomarker will take into account clinical factors (such as tumor stage, tumor size, and age), phenotypic characteristics of the tumor (determined by pathological immunohistochemistry and ex vivo ChemoResponse assay), and genotypic characteristics of the tumor and patient (determined by genomic profiling via gene expression analysis of tumor RNA). It is expected that collective consideration of all of these factors will be more predictive of patient response to therapy than any of them alone.

Approximately 224 evaluable subjects will be recruited from approximately 30 US sites. Women with measurable operable invasive breast cancer diagnosed by core needle biopsy will be eligible for this study. Additional tumor specimens will be obtained prior to the start of chemotherapy via core needle biopsies to be used for the ex vivo ChemoResponse Assay and tumor genomic analysis (gene expression), respectively.

All subjects will receive neoadjuvant chemotherapy with one of two standard of care regimens that must consist of the following agents: doxorubicin (A), cyclophosphamide (C), and a taxane (T) such as docetaxel, paclitaxel, or Abraxane (nanoparticle albumin-bound paclitaxel \[nab-paclitaxel\]); or, docetaxel (T) and cyclophosphamide (C). These must be administered per NCCN guidelines by the treating physician.

Upon completion of chemotherapy treatment, women will undergo lumpectomy, modified radical mastectomy or other surgical procedure determined appropriate by the investigator and at that time will be evaluated for pathological response. At the time of lumpectomy, modified radical mastectomy, or other surgical procedure, additional tumor excess will be sent to Precision Therapeutics, Inc. (Precision) for exploratory analysis if there is no pathologic complete response (pCR), if there are sufficient tumor cells to send, and if the patient agrees to have her excess tumor cells sent to Precision for this purpose.

During the patient's course of participation on the study, the treating physician will remain blinded to the results of the ChemoResponse Assay and genomic analysis. If it is determined there is no pCR at the time of lumpectomy, modified radical mastectomy or other surgical procedure, Precision will make available a subsequent report to the physician containing additional information about chemotherapy drugs other than ACT that could benefit the further treatment decisions for the patient.

Core needle biopsy specimens will be collected and stored in RNAlater® until the time of RNA extraction, using standard procedures. Isolated total RNA will be assayed for gene expression using methods such as TaqMan® RT-PCR technology or Affymetrix or Agilent gene array platforms.

Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer

United States Department of Defense

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ChemoFx® PRO - A Post-Market Data Collection Study	NCT00669422	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Uterine Neoplas... Endometrial Can... Vaginal Cancer Vulvar Cancer Cervical Cancer		18 Years -	Precision Therapeutics
ChemoFx® PRO - A Post-Market Data Collection Study	NCT00669422	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Uterine Neoplas... Endometrial Can... Vaginal Cancer Vulvar Cancer Cervical Cancer		18 Years -	Precision Therapeutics
Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients	NCT01049126	Endometrial Can...	ChemoFx	18 Years -	Precision Therapeutics
Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer	NCT01007890	Breast Cancer	ChemoFX Assay	18 Years -	Precision Therapeutics
ChemoFx® PRO - A Post-Market Data Collection Study	NCT00669422	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Uterine Neoplas... Endometrial Can... Vaginal Cancer Vulvar Cancer Cervical Cancer		18 Years -	Precision Therapeutics
Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer	NCT01007890	Breast Cancer	ChemoFX Assay	18 Years -	Precision Therapeutics

Spots Global Cancer Trial Database for chemofx

Every month we try and update this database with for chemofx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for chemofx

Every month we try and update this database with for chemofx cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for chemofx cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.