Clinical trial · Observational
Genetic Analysis of Blood and Tissue Samples From Patients With Advanced Cancer, Moonshot Study
NCORP Tissue Procurement Protocol: An NCI Cancer Moonshot Study
NCT03707574CI-TRIAL-00102398completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (54)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Advanced Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIC Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IV Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ancillary-correlative (genetic analysis)
- description
- 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.
- interventionNames
- Procedure: Biospecimen Collection
Primary outcomes (1)
- measure
- Obtaining tumor tissue and blood specimens
- timeFrame
- Up to 2 years
- description
- 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 outcomes (2)
- measure
- Tumor tissues storage in the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH) (Biorepository)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 siteReferences
Publications (0)
Data not yet available
No reference posted for this study.