Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study

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: NCT03707574
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This trial studies the genetic analysis of blood and tissue samples from patients with cancer that has spread to other anatomic sites (advanced) or is no longer responding to treatment. Studying these samples in the laboratory may help doctors to learn how genes affect cancer and how they affect a person's response to treatment.

Condition or disease Intervention/treatment
Advanced Malignant Neoplasm Advanced Melanoma Advanced Renal Cell Carcinoma Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Anatomic Stage IV Breast Cancer AJCC v8 Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage IV Breast Cancer AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage III Lung Cancer AJCC v8 Stage III Ovarian Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIA Lung Cancer AJCC v8 Stage IIIA Ovarian Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIA1 Ovarian Cancer AJCC v8 Stage IIIA2 Ovarian Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIB Lung Cancer AJCC v8 Stage IIIB Ovarian Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IIIC Lung Cancer AJCC v8 Stage IIIC Ovarian Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IV Lung Cancer AJCC v8 Stage IV Ovarian Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVA Lung Cancer AJCC v8 Stage IVA Ovarian Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVB Lung Cancer AJCC v8 Stage IVB Ovarian Cancer AJCC v8 Stage IVB Prostate Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8 Procedure: Biospecimen Collection

Detailed Description:

PRIMARY OBJECTIVES:

I. To procure paired newly acquired tumor tissues and blood at baseline and upon progression in patients treated for advanced cancer with molecularly targeted therapies at National Cancer Institute Community Oncology Research Program (NCORP) sites.

II. To bank formalin-fixed, paraffin-embedded (FFPE) tissue, blood (for cell-free deoxyribonucleic acid [DNA] analysis), and nucleic acids from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.

III. To bank, when available, optional snap-frozen tissue (for future to be determined analysis) from patients in the Biorepository, which is the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH), that may be used to study mechanisms of sensitivity and resistance to cancer therapies.

IV. To assess the feasibility of obtaining paired high-quality newly acquired tumor tissues and blood from patients being treated for advanced cancer in community-based healthcare settings (NCORP sites).

SECONDARY OBJECTIVES:

I. To perform molecular profiling assays on matched malignant tumor and blood (including but not limited to whole exome and messenger ribonucleic acid [RNA] sequencing) in order to provide physicians and patients with a clinical report from a Clinical Laboratory Improvement Act (CLIA)-certified laboratory from tumor obtained at baseline and upon progression that may be used to guide further treatment planning.

II. To make available biospecimens for studies to define potential resistance biomarkers using genomic and proteomic-based assessment platforms.

III. To contribute genetic analysis data from coded specimens to Genomic Data Commons, a well annotated cancer molecular and clinical data repository, for current and future research; specimens will be annotated with key clinical data including presentation, diagnosis, staging, summary treatment, and outcome, if possible.

IV. To identify potential predictive and prognostic biomarkers beyond any genomic alteration by which treatment may be assigned.

V. To identify resistance mechanisms using genomic DNA- and RNA-based assessment platforms.

OUTLINE:

Patients undergo collection of blood and tumor prior to starting treatment and upon disease progression (second collection of blood and tumor only for patients who do not continue to progress and achieve either an objective response [OR] or stable disease [SD] after 6 months of treatment). Samples are banked and analyzed via next generation sequencing.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: NCORP Tissue Procurement Protocol: An NCI Cancer Moonshot Study
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023


Group/Cohort Intervention/treatment
Ancillary-correlative (genetic analysis)
Patients undergo collection of blood and tumor prior to starting treatment and upon disease progression (second collection of blood and tumor only for patients who do not continue to progress and achieve either an OR or SD after 6 months of treatment). Samples are banked and analyzed via next generation sequencing.
Procedure: Biospecimen Collection
Undergo collection of blood and tissue




Primary Outcome Measures :
  1. Obtaining tumor tissue and blood specimens [ Time Frame: Up to 2 years ]
    Will obtain tumor tissue and blood specimens for biobanking and to store tissues, blood, and nucleic acids for future research, including the study of matched pre and post-treatment tumor biopsies to elucidate mechanisms of resistance. Cases will be grouped according to histology and/or treatment.


Secondary Outcome Measures :
  1. Tumor tissues storage in the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH) (Biorepository) [ Time Frame: Up to 2 years ]
  2. Genomic analysis [ Time Frame: Up to 2 years ]
    Will perform genomic studies, including a pan-cancer gene panel, and contribute molecular data to the genomic data commons.


Biospecimen Retention:   Samples With DNA
Blood, tissue


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
Patients treated for advanced cancer with molecularly targeted therapies at NCORP sites
Criteria

Inclusion Criteria:

  • Patient meets all eligibility criteria for treatment of the tumors with the agents listed and has agreed to provide tissue and blood samples for this study

    • Targeted therapy maybe as a singular/monotherapy or in combination with any Food and Drug Administration (FDA)-approved chemotherapies
    • Patient's primary or recurrent disease is targeted-treatment naive or will be treated with a targeted therapy listed different from any previously-received targeted therapy or combination therapy as standard of care
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. Patients with a PS of 2 may be enrolled only at the discretion of the treating physician and radiologist
  • Have an advanced malignancy being treated with one of the agents listed. Advanced cancer is cancer that is unlikely to be cured or controlled with treatment. The cancer may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Treatment may be given to help shrink the tumor, slow the growth of cancer cells, or relieve symptoms. Patients may be undergoing first or subsequent lines of therapy. In the case where an agent not listed is newly approved for one of the listed tumors, patients undergoing therapy with it will be able to enroll at discretion of the principal investigator (PI). This is to avoid any lag between FDA approval of a previously investigational agent and protocol modifications/updates
  • Have an advanced malignancy that meets one of the following criteria:

    • Patients must have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling. The biopsy must not be associated with a significant risk of severe or major complications or death. In particular, endoscopic, open or laparoscopic surgical procedures are not to be performed to provide research specimens. However, research specimens may be provided if the patient needs to undergo such procedures for clinical reasons
    • Severe or major complications are considered to be those

      • Requiring therapy, minor hospitalization (more than overnight but < 48 hours [h])
      • Requiring major therapy; unplanned increase in level of care, prolonged hospitalization > 48 h
      • Resulting in permanent adverse sequelae
      • Resulting in death
    • Patient will be undergoing a procedure due to medical necessity during which the tissue may be collected. The following tumors may be collected only under the conditions specified and not for the sole purpose of the clinical trial:

      • Brain biopsies: ONLY if the patient has medical necessity for craniotomy for clinical care
      • Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies: ONLY to be obtained incidentally to a clinically necessary procedure

Exclusion Criteria:

  • Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
  • Patients currently enrolled or planning to be co-enrolled (while participating on the 10231 study) on a therapeutically interventional clinical trial aimed to treat the current malignancy
  • If the patient is on chronic anticoagulation treatment, they must be able and willing to have this treatment discontinued for the biopsy. Discontinuation procedures will be those of the treating site

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): NCT03707574


Locations
Show Show 144 study locations
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: S. P Ivy National Cancer Institute (NCI)
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03707574    
Other Study ID Numbers: NCI-2018-01375
NCI-2018-01375 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10231 ( Other Identifier: National Cancer Institute )
10231 ( Other Identifier: CTEP )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
URL: https://grants.nih.gov/policy/sharing.htm

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Colorectal Neoplasms
Adenocarcinoma
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Esophageal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Prostatic Diseases
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial