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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for all trials

Timeline

Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach

2 countries

144 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.5 years study duration

First Submitted

Initial submission to the registry

October 12, 2018

Completed

4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed

9 months until next milestone

Study Start

First participant enrolled

July 16, 2019

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed

1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2026

Completed

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

October 12, 2018

Last Update Submit

February 3, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

Obtaining tumor tissue and blood specimens
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.
Up to 2 years

Secondary Outcomes (2)

Tumor tissues storage in the Biopathology Center (BPC) at Nationwide Children's Hospital (NCH) (Biorepository)
Up to 2 years
Genomic analysis
Up to 2 years

Study Arms (1)

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

Interventions

Biospecimen CollectionPROCEDURE

Undergo collection of blood and tissue

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Ancillary-correlative (genetic analysis)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

National Cancer Institute (NCI)lead

Study Sites (144)

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza