ctDNA og organbevaring/patologisk CR ved rektalkreft
En studie av rollen til sirkulerende tumor-DNA i å forutsi sannsynligheten for organbevaring eller patologisk fullstendig respons etter neoadjuvant terapi for rektalkreft
This prospective observational, non-therapeutic study for patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
This research study involves the collection of data and biospecimens (blood and tissue) to see if the presence of circulating tumor DNA (genetic material) ctDNA will help monitor rectal cancer more closely and potentially detect a recurrence before routine scans, performed per standard of care
C2i Genomics, a biotechnology company, and the Spier Foundation are supporting this research study by providing funding for the study.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
The research study procedures include screening for eligibility and the collection of data and biospecimens. Non-operative management is offered as part of routine clinical care.
It is expected that up to 60 participants will be enrolled, with the goal that 55 participants will take part in this research study .
Participants enrolled on the study will remain on study for up to 60 months.
Studietype
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy.
Beskrivelse
Inclusion Criteria:
- Participants with T3, T4, or node-positive non-metastatic rectal cancer.
- Participants must have original tumor tissue (formalin-fixed, paraffin embedded specimens) available for analysis or be willing to undergo a baseline research biopsy.
- Participants must be 18 years of age or older.
- ECOG 0-2.
- Participants must be eligible for at least 3 months of FOLFOX, FOLFIRINOX/FOLFOXIRI, or CAPOX
- Participants must be eligible for long course chemoradiation to 40-54 Gy.
- Participants must be able to understand and willing to sign a written informed consent document.
Exclusion Criteria:
- Participants must not have any other organ cancer evident at the time of enrollment.
- Participants may not have any other concurrent serious illness that makes participation on this study impractical or clinically inappropriate.
- Participants must not be actively or planning to be pregnant or breastfeeding
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
EVALUATION OF CTDNA
This prospective observational, non-therapeutic study will enroll patients with T3, T4, or node positive rectal cancer eligible to undergo total neoadjuvant therapy/ All procedures involved with this trial will be done as per standard of care - Except for the initial research biopsy, quality of life assessments and ctDNA collection |
initial research biopsy, quality of life assessments and ctDNA collection |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Frekvens for vellykket ikke-operativ ledelse
Tidsramme: 1 år
|
1 år
|
|
Frekvens for vellykket patologisk fullstendig respons
Tidsramme: 1 år
|
1 år
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of local recurrence
Tidsramme: 5 years
|
Local recurrence is defined as cancer coming back is in the same place as the original cancer or very close to it. Local recurrence will be assessed in participants who achieved a Clinical Complete Response (cCR) or Near Complete Clinical Response (nCR) after rectal cancer treatment by ctDNA status with the C2i assay. |
5 years
|
|
EORTC-QLQ-CR 29 questionnaire
Tidsramme: Up to 30 months
|
European Organization for Research and Treatment of Cancer-Colorectal surgery (EORTC-QLQ-CR 29) is a 29-item patient-reported questionnaire to assess health-related quality of life in patients with colorectal cancer. Each question ranges in score from 1 to 4. Higher scores indicate higher levels of symptoms or less functioning. |
Up to 30 months
|
|
FACT-C questionnaire
Tidsramme: Up to 30 months
|
Functional Assessment of Cancer Therapy- Colorectal (FACT-C) is a 37-item patient-reported questionnaire to assess quality of life in patients with colorectal. FACT-C questions are divided into four primary quality of life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Participants rate each item on the questionnaire from 0 to 4. Total score range is from 0 to 136. Higher scores generally indicate better quality of life. |
Up to 30 months
|
|
IADL Scale
Tidsramme: Up to 30 months
|
Instrumental Activities of Daily Living (IADL) Scale is an 8-item patient-reported questionnaire with a summary score from 0 (low function) to 8 (high function). IADLs are things you do every day to independently take care of yourself and your home. |
Up to 30 months
|
|
Brief Pain Inventory (BPI) questionnaire
Tidsramme: Up to 30 months
|
Brief Pain Inventory (BPI) is a questionnaire to measure the severity and interference of pain on daily functions in participants with cancer. BPI scale total score:
|
Up to 30 months
|
|
Bowel function assessment with LARS score
Tidsramme: Up to 30 months
|
Low Anterior Resection Syndrome (LARS) score (LARS) is a 5-item questionnaire to assess bowel dysfunction following a low anterior resection for rectal cancer. LARS total score:
|
Up to 30 months
|
|
Bowel function assessment with FISI score
Tidsramme: Up to 30 months
|
Fecal Incontinence Severity Index (FISI) is a patient-reported questionnaire that helps quantify the impact of adult incontinence leakage on quality of life. Total score range is from 0 to 61. Higher scores indicate a higher perceived severity of fecal incontinence and related impact on quality of life. |
Up to 30 months
|
|
Bowel function assessment with FIQOL score
Tidsramme: Up to 30 months
|
Fecal Incontinence Quality of Life (FIQOL) is a 29-item patient-reported questionnaire to assess quality of life of participants with fecal incontinence. The questionnaire has 4 subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. Subscale scores range from 1 to 5 and are the average response to all items on each scale. Total FIQOL score is the sum of all four subscales. Lower scores indicate lower functional status and related quality of life. |
Up to 30 months
|
|
Disease-free survival (DFS)
Tidsramme: Up to 30 months
|
Disease-free survival (DFS) is defined as the length of time after completion of rectal cancer treatment that the patient survives without any signs or symptoms of that cancer. |
Up to 30 months
|
|
Overall Survival (OS)
Tidsramme: Up to 30 months
|
Overall survival (OS) is defined as the length of time after starting rectal cancer treatment that participants are still alive. |
Up to 30 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hannah J. Roberts, MD, Massachusetts General Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 22-244
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Data can be shared no earlier than 1 year following the date of publication
Tilgangskriterier for IPD-deling
Contact the Partners Innovations team at http://www.partners.org/innovation
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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