Gastrointestinal CancerSURGENCT05375643
SURGE: Supporting Utility and Representation in Genomics-based Cancer Trial Enrollment (Intervention)
A study testing SURGE in people with Gastrointestinal Cancer and Hematologic Cancer, run by Nadine Jackson, MD, MPH at 3 sites in United States.
Trial summary
SURGE aims to increase representation in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer
- What is being tested?
- SURGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Apr 2023to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age 18 years or older)
- Scheduled for a new patient consultation
- Suspected or confirmed advanced malignancy (requiring active treatment)
- DFCI patient at Longwood/Chestnut Hill, DFCI satellite at BMC-Brighton (formerly St. Elizabeth's Medical Center), DFCI satellite at Foxborough, or DFCI satellite at Merrimack Valley
Who cannot join
- Malignancy or former malignancy that requires only surveillance
- Not continuing care at a participating DFCI site
- Speaks a language other than English, Spanish, Haitian Creole, Russian, Portuguese, Arabic, or Traditional Chinese
- Unable to provide consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Nadine J. McCleary, MD, MPH, (617) 632-6729, nj_mccleary@dfci.harvard.edu
Nadine J. McCleary, MD, MPH
- Recruiting
Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135
Olga Kozyreva, MD, olga_kozyreva@dfci.harvard.edu
Olga Kozyreva, MD
- Not yet recruiting
Dana-Farber Cancer Instiute - Merrimack Valley
Methuen, Massachusetts, 01844
Pedro Sanz-Altamira, MD, pedro_sanz-altamira@dfci.harvard.edu
Pedro Sanz-Altamira, MD
About this study
SURGE aims to increase representation in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. The study is an interventional pilot meant primarily to assess the feasibility of the intervention. The intervention is comprised of a patient navigator, text message questionnaire, and informational video.
Read the detailed description
Supporting Utility and Representation in Genomics-based cancer trial Enrollment (SURGE) is a multimodal intervention to address medical literacy and unmet social determinants of health (SDoH) needs as barriers to tumor somatic genomic testing consent among historically underrepresented patients (HUP) diagnosed with advanced solid or hematologic malignancies as a prerequisite to precision therapies and/or clinical trial eligibility. Our key hypothesis is that video-based education with or without 1:1 patient navigation will address medical literacy and unmet SDoH barriers, supporting HUP decision-making about genomic tumor consent. We will conduct a type 1 hybrid implementation effectiveness study among a cohort of HUP seeking medical oncology care at two academic and two community practice sites.
- Conditions
- Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer
- Being tested
- SURGE
- Keywords
- Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer
- Medical subject headings
- Gastrointestinal Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURGEBehavioural
Video with or without person to person guidance to support decision making around genetic testing
| Study group | Role | What they receive |
|---|---|---|
| Arm B (informational video) | Experimental | Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive:
* Informational Video Receives: Behavioral: SURGE |
| Arm A (standard of care) | No intervention | Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to Standard of Care (SOC) and receive: * Standard of Care |
| Arm C (informational video and patient navigation) | Experimental | Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive:
* Informational Video and Patient Navigation Receives: Behavioral: SURGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic testing uptake
Intervention impact on rate of uptake of genomic testing
Measured: Up to 90 days of enrollment
Secondary outcomes (2)
Patient interaction with the intervention
Interaction with each component of the intervention (as appropriate by intervention arm)
Measured: Up to 30 days of enrollment
Acceptability of questionnaire modality
We will use the System Usability Scale to measure usability of the questionnaire electronic tool. The 10-item System Usability Scale is scored on a five-point Likert scale, with 1 being Strongly Disagree and 5 being Strongly Agree.
Measured: Up to 30 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start3 Apr 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nadine Jackson, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Nadine Jackson, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Nadine A Jackson, MD MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05375643
- Sponsor's protocol ID
- 21-709
- Acronym
- SURGE
- Status last verified
- Sep 2025
- First submitted
- 11 May 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURGE: Supporting Utility and Representation in Genomics-based Cancer Trial Enrollment (Intervention)
- ClinicalTrials.gov ID
- NCT05375643
- Acronym / sponsor ID
- SURGE / 21-709
- Conditions
- Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer
- Keywords
- Gastrointestinal Cancer, Hematologic Cancer, Thoracic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Nadine Jackson, MD, MPHUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SURGE aims to increase representation in clinical trial enrollment by addressing barriers to genomic testing, which is increasingly needed to assess precision clinical trial eligibility and access standard precision therapies. The study is an interventional pilot meant primarily to assess the feasibility of the intervention. The intervention is comprised of a patient navigator, text message questionnaire, and informational video.
Detailed description
Supporting Utility and Representation in Genomics-based cancer trial Enrollment (SURGE) is a multimodal intervention to address medical literacy and unmet social determinants of health (SDoH) needs as barriers to tumor somatic genomic testing consent among historically underrepresented patients (HUP) diagnosed with advanced solid or hematologic malignancies as a prerequisite to precision therapies and/or clinical trial eligibility. Our key hypothesis is that video-based education with or without 1:1 patient navigation will address medical literacy and unmet SDoH barriers, supporting HUP decision-making about genomic tumor consent. We will conduct a type 1 hybrid implementation effectiveness study among a cohort of HUP seeking medical oncology care at two academic and two community practice sites.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm B (informational video) | Experimental | Behavioral: SURGEParticipants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive: * Informational Video |
| Arm A (standard of care) | No intervention | –Participants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to Standard of Care (SOC) and receive: * Standard of Care |
| Arm C (informational video and patient navigation) | Experimental | Behavioral: SURGEParticipants will complete screening questionnaire via text or by phone to establish baseline awareness and interest in clinical trials and then randomized to the SURGE intervention where they will receive: * Informational Video and Patient Navigation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (age 18 years or older)
- Scheduled for a new patient consultation
- Suspected or confirmed advanced malignancy (requiring active treatment)
- DFCI patient at Longwood/Chestnut Hill, DFCI satellite at BMC-Brighton (formerly St. Elizabeth's Medical Center), DFCI satellite at Foxborough, or DFCI satellite at Merrimack Valley
Key exclusion criteria (4 listed)
- Malignancy or former malignancy that requires only surveillance
- Not continuing care at a participating DFCI site
- Speaks a language other than English, Spanish, Haitian Creole, Russian, Portuguese, Arabic, or Traditional Chinese
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SURGEVideo with or without person to person guidance to support decision making around genetic testing | Behavioural | Arm B (informational video), Arm C (informational video and patient navigation) |
Primary outcome
Genomic testing uptake
Time frame: Up to 90 days of enrollment
Intervention impact on rate of uptake of genomic testing
2 secondary outcomes
Patient interaction with the intervention
Time frame: Up to 30 days of enrollment
Acceptability of questionnaire modality
Time frame: Up to 30 days of enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine A Jackson, MD MPH principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURGE in people with Gastrointestinal Cancer and Hematologic Cancer, run by Nadine Jackson, MD, MPH at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine A Jackson, MD MPH ((617) 632-6729, na_jackson@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genomic testing uptake (time frame: Up to 90 days of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.