Cancer RiskNCT05463796
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
An observational study of Cancer Risk and Cancer Predisposition Syndrome, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer Risk, Cancer Predisposition Syndrome, Hereditary Cancer Prediction
- What is being tested?
- Samples
- Type of treatment
- Pill or oral medicine
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2023to 25 Mar 2031
- How long will I take part?
- 20 Years
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type Hereditary risk for cancer, Exposed High Risk, Precursor Lesions, FAMILY MEMBERS
Who may be able to join
- Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):
- 1-Hereditary risk for cancer including
- Carriers of known or previously unrecognized pathogenic germline variants of cancer predisposing genes
- Individuals with personal or family history suggestive of elevated cancer risk (this may include individuals who have negative genetic testing results or have not elected to undergo testing)
- Individuals with a clinically based diagnosis of a Cancer Predisposition Syndrome (examples, neurofibromatosis, Fanconi Anemia, Ataxia-Telangiectasia)
- Hereditary Cancer Prediction Model-based elevated cancer risk
Show all 25Show fewer
- Others at risk for specific cancers by virtue of exposure, obesity, gender, race and ethnicity, HPV exposure (for H\&N cancer for example), etc.
- Exposed High Risk including
- Childhood cancer survivors with treatment exposures associated with increased risk of cancer
- Adult cancer survivors with treatment exposures associated with increased risk of cancer
- Documented high level exposure to group 1 IARC carcinogens
- Thoracic: individuals at risk for lung cancer including but not exclusive of the following criteria: Age >50, Smoking history of >15 pack years, First-degree relative history of lung cancer or COPD
- alcoholic liver disease (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis
- Precursor Lesions including
- Breast: ductal/lobular carcinoma in situ (CIS) and atypical hyperplasia
- GI: Barrett's esophagus, Pancreatic precursor lesions, colonic dysplasia/adenomata, nonalcoholic fatty liver (NAFL), nonalcoholic steatohepatitis (NASH), cirrhosis
- GU: High grade prostatic epithelial neoplasia, and high-grade bladder urothelial dysplasia/carcinoma in situ,
- Lung: Adenomatous hyperplasia
- H\&N: high-risk oral precancerous diseases
- Skin: Class II melanocytic lesions. Squamous dysplasia
- Heme malignancies: CHIP, CCUS, ICUS, MGUS, SMM, SWM, MBL (spell these out), Low grade lymphomas
- Thoracic: Lung nodules detected on screening CT that prompt further follow-up
- GYN: STIC lesion (serous tubal intraepithelial carcinoma), Endometrial intraepithelial neoplasia, Cervical and endocervical carcinoma in situ, vulvar intraepithelial neoplasia
- Pediatric histologic diagnoses sometimes associated with development of malignancy: Nephrogenic rests, benign bone lesions with risk of malignant degeneration (Giant cell tumor, osteochondroma), Spitz nevus, and others.
- FAMILY MEMBERS or healthy individuals
Who cannot join
- There are no exclusion criteria for the study.
- Note: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tia Kauffman, MPH contact
United States1 site, 1 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Sapna Syngal, MD, 617-632-5022, SSYNGAL@PARTNERS.ORG
Sapna Syngal, MD
About this study
Official title: InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer
This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer.
- The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.
- The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.
Read the detailed description
The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation.
- Blood, buccal swabs, urine or tissue or other body fluids (including stool) may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes.
- These materials will be collected from all eligible participants who have a precursor lesion or an increased risk of cancer
It is expected that about 5,000 people will take part in this research study.
- Conditions
- Cancer Risk, Cancer Predisposition Syndrome, Hereditary Cancer Prediction, Childhood Cancer Survivors, Adult Cancer Survivors, IARC Carcinogens
- Being tested
- Samples
- Keywords
- Hereditary Risk for Cancer, Childhood cancer survivors, Adult cancer survivors, Precursor Lesions
- Medical subject headings
- Lung Neoplasms, Carcinoma, Lobular, Barrett Esophagus, Non-alcoholic Fatty Liver Disease, Fibrosis, Carcinoma in Situ, Hematologic Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesOther
Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types:
Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues
| Study group | Role | What they receive |
|---|---|---|
| HEREDITARY RISK | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data.
Tissue samples will be collected during a routine visit.
Participants will be asked to donate any of the following tissue types:
* Blood
* Buccal swab (saliva) or mouthwash
* Urine
* Stool
* Biopsy or surgical tissue (i.e., bone marrow)
* Bodily fluids
* Other tissues Receives: Other: Samples | |
| EXPOSED HIGH RISK | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data.
Tissue samples will be collected during a routine visit.
Participants will be asked to donate any of the following tissue types:
* Blood
* Buccal swab (saliva) or mouthwash
* Urine
* Stool
* Biopsy or surgical tissue (i.e., bone marrow)
* Bodily fluids
* Other tissues Receives: Other: Samples | |
| PRECURSOR LESIONS | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data.
Tissue samples will be collected during a routine visit.
Participants will be asked to donate any of the following tissue types:
* Blood
* Buccal swab (saliva) or mouthwash
* Urine
* Stool
* Biopsy or surgical tissue (i.e., bone marrow)
* Bodily fluids
* Other tissues Receives: Other: Samples | |
| FAMILY MEMBERS | These family members will be identified by the patients participating in the study. Blood, buccal cells, or saliva or oral rinses will be collected in one of three ways from family members of patients (i) at the time of consent; (ii) via a mailed blood kit or saliva kit; or (iii) at a separate appointment scheduled by the consented participant Receives: Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.
The InAdvance Study will screen participants for precancerous conditions and cancer through blood tests and tissue biopsies. These biologic samples will be screened for precancerous conditions through routine clinical methods, as well as using novel research level technology. This could include germline testing, whole genome and whole exome sequencing. The participants will be followed serially to track their disease progression. Participants will fill out general health questionnaires, and we will match their answers to the timepoint of their sample submission and follow changes to their answers.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start25 Apr 2023
- Primary completion25 Mar 2030 (estimated)
- Study completion25 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cancer RiskStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sapna Syngal, MD, MPH, Dana-Farber Cancer Institute
- Investigators
- Sapna Syngal, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463796
- Sponsor's protocol ID
- 22-200
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2022
- Last updated
- 17 Aug 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 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.
Publications
Kauffman TL, O'Donnell EK, Marinac CR, Babic A, Adams K, Beckwith JB, Berman TA, Brantley KD, Chowdhury D, Crompton BD, Diller LR, Elias KM, Feltmate CM, Florez N, Garber JE, Ghobrial I, Hanna GJ, Hormoz S, Kamihara J, LeBoeuf NR, Mittendorf EA, Partridge AH, Rodriguez NJ, Sands J, Thapa B, Weeks LD, Woo SB, Yurgelun MB, Parmigiani G, Rebbeck TR, Syngal S. A Longitudinal Comprehensive Biospecimen and Clinical Data Repository for Cancer Early Detection: The InAdvance Study. Cancer Epidemiol Biomarkers Prev. 2026 Jul 1;35(7):1076-1087. doi: 10.1158/1055-9965.EPI-25-1684.
PubMed 42059770O'Donnell EK, Kauffman TL, Asnis S, Kelly VA, Matthews E, Kartsounis M, Dharaneeswaran H, Beckwith JB, Bennett C, Marto M, Parmigiani G, Rebbeck TR, Ghobrial IM, Syngal S, Marinac CR. Diagnostic Outcomes among Patients with Positive Multi-Cancer Early Detection Test Results. Cancer Res Commun. 2026 Mar 1;6(3):511-515. doi: 10.1158/2767-9764.CRC-25-0723.
PubMed 41721625
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InAdvance: Surveillance, Prevention, and Interception in a Population at Risk For Cancer
- ClinicalTrials.gov ID
- NCT05463796
- Acronym / sponsor ID
- 22-200
- Conditions
- Cancer Risk, Cancer Predisposition Syndrome, Hereditary Cancer Prediction, Childhood Cancer Survivors, Adult Cancer Survivors, IARC Carcinogens
- Keywords
- Hereditary Risk for Cancer, Childhood cancer survivors, Adult cancer survivors, Precursor Lesions
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 25 Mar 2030 (estimated)
- Study completion
- 25 Mar 2031 (estimated)
- First posted
- 19 Jul 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.
This research study is creating a way to collect and store specimens and information from participants who may be at an increased risk of developing cancer, or has been diagnosed with an early phase of a cancer or a family member who has a family member with a precursor condition for cancer.
- The objective of this study is to identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.
- The ultimate goal is to identify novel markers of early detection and risk stratification to drive potential therapeutic approaches to intercept progression to cancer.
Detailed description
The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation.
- Blood, buccal swabs, urine or tissue or other body fluids (including stool) may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes.
- These materials will be collected from all eligible participants who have a precursor lesion or an increased risk of cancer
It is expected that about 5,000 people will take part in this research study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HEREDITARY RISK | – | Other: SamplesParticipants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: * Blood * Buccal swab (saliva) or mouthwash * Urine * Stool * Biopsy or surgical tissue (i.e., bone marrow) * Bodily fluids * Other tissues |
| EXPOSED HIGH RISK | – | Other: SamplesParticipants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: * Blood * Buccal swab (saliva) or mouthwash * Urine * Stool * Biopsy or surgical tissue (i.e., bone marrow) * Bodily fluids * Other tissues |
| PRECURSOR LESIONS | – | Other: SamplesParticipants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: * Blood * Buccal swab (saliva) or mouthwash * Urine * Stool * Biopsy or surgical tissue (i.e., bone marrow) * Bodily fluids * Other tissues |
| FAMILY MEMBERS | – | Other: SamplesThese family members will be identified by the patients participating in the study. Blood, buccal cells, or saliva or oral rinses will be collected in one of three ways from family members of patients (i) at the time of consent; (ii) via a mailed blood kit or saliva kit; or (iii) at a separate appointment scheduled by the consented participant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type Hereditary risk for cancer, Exposed High Risk, Precursor Lesions, FAMILY MEMBERS
Key inclusion criteria (25 listed)
- Participants to be included in this study include the following (note that this list is not comprehensive but gives examples of precursor conditions for each organ type):
- 1-Hereditary risk for cancer including
- Exposed High Risk including
- Precursor Lesions including
- FAMILY MEMBERS or healthy individuals
Key exclusion criteria (2 listed)
- There are no exclusion criteria for the study.
- Note: Patients with prior cancer history are allowed to participate. Patients with prior history of cancer or non-metastatic localized cancers (such as skin cancer or localized prostate cancer) are allowed to be enrolled. Patients enrolled in clinical trials or receiving therapy for precursor diseases are NOT excluded from this study.
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 |
|---|---|---|
| SamplesTissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues | Other | EXPOSED HIGH RISK, FAMILY MEMBERS, HEREDITARY RISK, PRECURSOR LESIONS |
Primary outcome
Identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal.
Time frame: 5 years
The InAdvance Study will screen participants for precancerous conditions and cancer through blood tests and tissue biopsies. These biologic samples will be screened for precancerous conditions through routine clinical methods, as well as using novel research level technology. This could include germline testing, whole genome and whole exome sequencing. The participants will be followed serially to track their disease progression. Participants will fill out general health questionnaires, and we will match their answers to the timepoint of their sample submission and follow changes to their answers.
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 17 Aug 2026.
- Background: PubMed 42059770Kauffman TL, O'Donnell EK, Marinac CR, Babic A, Adams K, Beckwith JB, Berman TA, Brantley KD, Chowdhury D, Crompton BD, Diller LR, Elias KM, Feltmate CM, Florez N, Garber JE, Ghobrial I, Hanna GJ, Hormoz S, Kamihara J, LeBoeuf NR, Mittendorf EA, Partridge AH, Rodriguez NJ, Sands J, Thapa B, Weeks LD, Woo SB, Yurgelun MB, Parmigiani G, Rebbeck TR, Syngal S. A Longitudinal Comprehensive Biospecimen and Clinical Data Repository for Cancer Early Detection: The InAdvance Study. Cancer Epidemiol Biomarkers Prev. 2026 Jul 1;35(7):1076-1087. doi: 10.1158/1055-9965.EPI-25-1684.
- Derived from this study: PubMed 41721625O'Donnell EK, Kauffman TL, Asnis S, Kelly VA, Matthews E, Kartsounis M, Dharaneeswaran H, Beckwith JB, Bennett C, Marto M, Parmigiani G, Rebbeck TR, Ghobrial IM, Syngal S, Marinac CR. Diagnostic Outcomes among Patients with Positive Multi-Cancer Early Detection Test Results. Cancer Res Commun. 2026 Mar 1;6(3):511-515. doi: 10.1158/2767-9764.CRC-25-0723.
- Study website for enrollmentLink provided by the sponsor.
- 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 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.
Tia Kauffman, MPH contact
Sapna Syngal, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Risk and Cancer Predisposition Syndrome, run by Dana-Farber Cancer Institute at 1 site 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 25 inclusion and 2 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 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jenna Beckwith, MPH (857-215-1892, inadvancestudy@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify exposures as well as clinical, molecular, and pathological changes that can be used to predict early development of cancer, malignant transformation, and risks of progression to symptomatic cancer that can ultimately be fatal. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05463796, which also lists 2 linked publications.
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 17 Aug 2026.