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

Completed

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT03707574

Run by

National Cancer Institute (NCI)

People needed

64

Starts

2019-07-16

Expected to finish

2026-01-23

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States
• Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States
• Island Urology — Honolulu, Hawaii, United States
• Queen's Cancer Cenrer - POB I — Honolulu, Hawaii, United States
• Queen's Medical Center — Honolulu, Hawaii, United States
• Straub Clinic and Hospital — Honolulu, Hawaii, United States
• University of Hawaii Cancer Center — Honolulu, Hawaii, United States
• Hawaii Cancer Care Inc-Liliha — Honolulu, Hawaii, United States
• Kuakini Medical Center — Honolulu, Hawaii, United States
• Queen's Cancer Center - Kuakini — Honolulu, Hawaii, United States
• The Cancer Center of Hawaii-Liliha — Honolulu, Hawaii, United States
• Kapiolani Medical Center for Women and Children — Honolulu, Hawaii, United States
• Wilcox Memorial Hospital and Kauai Medical Clinic — Lihue, Hawaii, United States
• Hawaii Cancer Care - Westridge — ‘Aiea, Hawaii, United States
• Pali Momi Medical Center — ‘Aiea, Hawaii, United States
• Queen's Cancer Center - Pearlridge — ‘Aiea, Hawaii, United States
• The Cancer Center of Hawaii-Pali Momi — ‘Aiea, Hawaii, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Memorial Hospital of Carbondale — Carbondale, Illinois, United States
• SIH Cancer Institute — Carterville, Illinois, United States
• Illinois CancerCare-Carthage — Carthage, Illinois, United States
• Centralia Oncology Clinic — Centralia, Illinois, United States
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.