Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 19 of 33 for:    Vagina Sarcoma

The Master Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04028479
Recruitment Status : Not yet recruiting
First Posted : July 22, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Taproot Health

Brief Summary:
This is a multi-institutional effort to aggregate detailed genetic (and molecular) data in connection with treatments and physician reported outcomes in patients with advanced cancer.

Condition or disease Intervention/treatment
Adenocarcinoma Adenocystic Carcinoma Anal Cancer Appendix Cancer Brain Tumor Glioblastoma Astrocytoma Bile Duct Cancer Cholangiocarcinoma Bladder Cancer Bone Cancer Synovial Sarcoma Chondrosarcoma Liposarcoma Sarcoma, Kaposi Sarcoma,Soft Tissue Sarcoma Osteosarcoma CNS Cancer Brain Stem Neoplasms Breast Cancer Cervical Cancer Colorectal Cancer Rectal Cancer Colon Cancer Esophageal Cancer Esophagus Cancer Cancer of Colon Pancreatic Cancer Cancer of Pancreas Testis Cancer Testicular Cancer Ureter Cancer Renal Cell Carcinoma Kidney Cancer Gestational Trophoblastic Tumor Head and Neck Neoplasms Parotid Tumor Larynx Cancer Tongue Cancer Pharynx Cancer Salivary Gland Cancer Acute Myeloid Leukemia Chronic Myeloid Leukemia Acute Lymphoblastic Leukemia Multiple Myeloma Non Hodgkin Lymphoma Carcinoid Tumor Lung Cancer Neuroendocrine Tumors Mesothelioma Thyroid Cancer Parathyroid Neoplasms Adrenal Cancer Small Bowel Cancer Stomach Cancer Liver Cancer Hepatic Cancer Melanoma Skin Cancer Unknown Primary Tumors Uterine Cancer Fallopian Tube Cancer Ovarian Cancer Prostate Cancer Vaginal Cancer Penile Cancer Vulvar Cancer Waldenstrom Macroglobulinemia Cancer, Advanced Thymus Cancer Nasopharyngeal Carcinoma Multiple Endocrine Neoplasia Pheochromocytoma Small Cell Carcinoma Pulmonary Carcinoma Diagnostic Test: Testing: Genome Diagnostic Test: Testing: Transcriptome Diagnostic Test: Testing: Proteome Drug: Treatment: CAR-T

Detailed Description:
This is an observational trial (patient registry). Any patient who has been diagnosed with advanced cancer and whose tumor will be tested or treated by a standard of care testing or treatment method identified in the protocol will be included. Each patient will receive testing and treatment as determined is best by patient in consultation with physician. Tumor staging and any previous staging information will be collected. Each line of therapy will be recorded along with a physician determined response determined at all visits where the patient undergoes restating or change in therapy. Physician decision making and overall survival data is also collected.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: The Master Registry of Oncology Outcomes Associated With Testing and Treatment (ROOT)
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2029
Estimated Study Completion Date : October 1, 2031


Group/Cohort Intervention/treatment
Testing: Genome
Any patient whose tumor has been sequencing using a multiplex method such as next-generation sequencing including hot-spot, selected exome, whole exome, or whole genome testing
Diagnostic Test: Testing: Genome
Patients who receive genomic testing of their tumor as part of standard of care. This is an observational arm.
Other Names:
  • Next-generation sequencing (NGS)
  • Genomic analysis
  • Exome sequencing
  • DNA sequencing

Testing: Transcriptome
Any patient whose tumor has been tested for transcriptomic characteristics such as RNA sequencing
Diagnostic Test: Testing: Transcriptome
Patients who receive transcriptomic testing of their tumor as part of standard of care. This an observational arm.
Other Names:
  • Next-generation sequencing (NGS)
  • RNA sequencing
  • Transcriptomic analysis

Testing: Proteome
Any patient whose tumor has been tested for protein expression
Diagnostic Test: Testing: Proteome
Patients who receive proteomic testing of their tumor as part of standard of care. This is an observational arm.
Other Name: Protein expression testing

Treatment: CAR-T
Any patients who receive chimeric antigen receptor T cell (CAR-T) therapy
Drug: Treatment: CAR-T
Patients who receive CAR-T therapy as part of standard of care. This is an observational arm. Patients may have also received any diagnostic testing of their tumor such as genomic or transcriptomic testing.
Other Name: Chimeric antigen receptor T-cell therapy (CAR-T)




Primary Outcome Measures :
  1. Best overall response (BOR) - 1st line of therapy [ Time Frame: 1st line of therapy, on average less than 1 year ]
    The best overall response for 1st line of therapy as determined by physician assessment

  2. Best overall response (BOR) - 2nd line of therapy [ Time Frame: 2nd line of therapy, on average less than 1 year ]
    The best overall response for 2nd line of therapy as determined by physician assessment

  3. Best overall response (BOR) - 3rd line of therapy [ Time Frame: 3rd line of therapy, on average less than 1 year ]
    The best overall response for 3rd line of therapy as determined by physician assessment

  4. Best overall response (BOR) - 4th line of therapy [ Time Frame: 4th line of therapy, on average less than 1 year ]
    The best overall response for 4th line of therapy as determined by physician assessment

  5. Best overall response (BOR) - 5th line of therapy [ Time Frame: 5th line of therapy, on average less than 1 year ]
    The best overall response for 5th line of therapy as determined by physician assessment

  6. Progression-free survival (PFS) - 1st line of therapy [ Time Frame: 1st line of therapy, on average less than 1 year ]
    The progression free survival for 1st line of therapy as determined by physician assessment

  7. Progression-free survival (PFS) - 2nd line of therapy [ Time Frame: 2nd line of therapy, on average less than 1 year ]
    The progression free survival for 2nd line of therapy as determined by physician assessment

  8. Progression-free survival (PFS) - 3rd line of therapy [ Time Frame: 3rd line of therapy, on average less than 1 year ]
    The progression free survival for 3rd line of therapy as determined by physician assessment

  9. Progression-free survival (PFS) - 4th line of therapy [ Time Frame: 4th line of therapy, on average less than 1 year ]
    The progression free survival for 4th line of therapy as determined by physician assessment

  10. Progression-free survival (PFS) - 5th line of therapy [ Time Frame: 5th line of therapy, on average less than 1 year ]
    The progression free survival for 5th line of therapy as determined by physician assessment


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: through study completion, on average less than 3 years ]
    The overall survival of a patient from the time of being diagnosed with advanced disease until death


Biospecimen Retention:   Samples With DNA
Protocol does not require submission of samples, but catalogs location of specimens that can be requisitioned later


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient with advanced cancer who will receive molecular testing of their tumor and/or will receive a specific treatment as part of standard of care
Criteria

Inclusion Criteria:

  • patient or representative provides written informed consent
  • patient is diagnosed with advanced malignancy
  • patient is willing to be treated for this malignancy according to a plan determine by them and their physician
  • patient will be willing to have regular follow up visits as part of their standard of care
  • for CAR-T arm only, will receive CAR-T therapy as part of their standard of care

Exclusion Criteria:

  • patient is not a candidate for systemic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028479


Contacts
Layout table for location contacts
Contact: Judy Taylor (801) 396-5190 judy.taylor@taprootco.com
Contact: Jennifer Rock (801) 396-5190 jennifer.rock@taprootco.com

Sponsors and Collaborators
Taproot Health
Investigators
Layout table for investigator information
Study Chair: Razelle Kurzrock, MD Moores Cancer Center at University of California at San Diego
Principal Investigator: Vivek Subbiah, MD M.D. Anderson Cancer Center
Principal Investigator: Jennifer Johnson, MD, PhD Sidney Kimmel Cancer Center at Thomas Jefferson University
Principal Investigator: Raymond Bergan, MD OHSU Knight Cancer Institute

Publications of Results:
Other Publications:

Layout table for additonal information
Responsible Party: Taproot Health
ClinicalTrials.gov Identifier: NCT04028479     History of Changes
Other Study ID Numbers: ROOT
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will likely be shared, but will be determined by participating clinical sites.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taproot Health:
Precision Medicine
Molecular Sequence Data
Databases, Genetic
High-Throughput Nucleotide Sequencing
Massively-Parallel Sequencing
Observational Study
Treatment
Patient Outcome Assessment
Adaptive clinical trial
Molecular Typing
Response Rate
Progression Free Survival
Overall Survival
Additional relevant MeSH terms:
Layout table for MeSH terms
Sarcoma, Kaposi
Sarcoma
Vaginal Neoplasms
Sarcoma, Synovial
Vaginal Diseases
Carcinoma
Leukemia
Leukemia, Myeloid
Multiple Myeloma
Pancreatic Neoplasms
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Glioblastoma
Colonic Neoplasms
Carcinoma, Renal Cell
Esophageal Neoplasms
Liver Neoplasms
Astrocytoma
Mesothelioma
Fallopian Tube Neoplasms
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Neuroendocrine Tumors
Nasopharyngeal Carcinoma
Cholangiocarcinoma
Osteosarcoma
Waldenstrom Macroglobulinemia
Salivary Gland Neoplasms
Carcinoid Tumor
Anus Neoplasms
Bile Duct Neoplasms
Head and Neck Neoplasms